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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00643201
Registration number
NCT00643201
Ethics application status
Date submitted
20/03/2008
Date registered
26/03/2008
Date last updated
21/04/2014
Titles & IDs
Public title
Efficacy and Safety Study of Apixaban for the Treatment of Deep Vein Thrombosis or Pulmonary Embolism
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Scientific title
A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
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Secondary ID [1]
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EUDRACT: 2007-007867-25
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Secondary ID [2]
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CV185-056
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis
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0
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin
Treatment: Drugs - warfarin
Treatment: Drugs - Placebo for apixaban
Treatment: Drugs - Placebo for enoxaparin
Treatment: Drugs - Placebo for warfarin
Treatment: Drugs - apixaban
Active Comparator: Apixaban - apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
Experimental: Enoxaparin + Warfarin - Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) =2.
Treatment: Drugs: Enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until International normalized ratio (INR) =2.
Treatment: Drugs: warfarin
tablets, oral, dosing to target INR range between 2.0 - 3.0, once daily, 6 months
Treatment: Drugs: Placebo for apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by placebo for apixaban 5 mg tablets, twice daily, 6 months
Treatment: Drugs: Placebo for enoxaparin
solution, subcutaneous, 1 mg/kg Q12h until sham INR =2.
Treatment: Drugs: Placebo for warfarin
tablets, oral, dosing to target sham INR range between 2.0 - 3.0, once daily, 6 months
Treatment: Drugs: apixaban
tablets, oral, 10 mg tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
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Assessment method [1]
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VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).
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Timepoint [1]
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Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
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Secondary outcome [1]
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Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death
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Assessment method [1]
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VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie intent to treat (ITT) principle. Each participant scored as having an event only if they experienced one or more of the elements of the composite. Participants with missing endpoint information excluded.
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Timepoint [1]
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Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [2]
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Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death
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Assessment method [2]
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VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of efficacy evaluable participants, participants with missing endpoint information excluded). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received, ie, ITT principle. Each participant scored as having an event only if the participant experienced one or more of the elements of the composite.
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Timepoint [2]
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Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [3]
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Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding
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Assessment method [3]
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VTE included: nonfatal DVT or nonfatal PE. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major bleeding defined by International Society on Thrombosis and Haemostasis: acute, clinically overt bleeding associated with decrease in hemoglobin (Hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or bleeding that is fatal . Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period. Events included regardless of whether or not participant received treatment, ie, ITT principle
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Timepoint [3]
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Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [4]
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Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding
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Assessment method [4]
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VTE=Nonfatal DVT or nonfatal PE adjudicated by ICAC blinded to treatment. DVT: compression ultrasound and/or venography; PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Major Bleeding = acute, clinically overt bleeding: decrease in Hgb of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint and including those not in the efficacy evaluable population with a bleeding event that occurred during treatment period). Events included regardless of whether or not treatment was received (ITT).
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Timepoint [4]
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Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [5]
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Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period
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Assessment method [5]
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DVT adjudicated by an ICAC blinded to treatment. DVT evaluated by: compression ultrasound and/or venography. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication, intent to treat principle (ITT). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).
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Timepoint [5]
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Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [6]
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Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period
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Assessment method [6]
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PE adjudicated by an ICAC blinded to treatment. PE: spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early).
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Timepoint [6]
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Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [7]
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Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period
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Assessment method [7]
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VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT was assessed by compression ultrasound and/or venography; PE was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).
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Timepoint [7]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [8]
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Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period
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Assessment method [8]
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VTE-related death included: DVT-related death or PE-related death. All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of participants with observation; N=total number of participants in respective treatment groups excluding participants with missing endpoint information). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occur during the intended treatment period regardless of whether or not the participant received study medication (ITT principle).
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Timepoint [8]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [9]
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Incidence of All-Cause Death During the Intended Treatment Period
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Assessment method [9]
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Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Includes events that occurred during the intended treatment period, regardless of whether the participant received study medication (ITT principle). Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants, excluding those with missing endpoint information).
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Timepoint [9]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [10]
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Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants
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Assessment method [10]
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All events were adjudicated by an ICAC blinded to treatment. Bleeding defined by International Society on Thrombosis and Haemostasis: Major Bleeding: acute, clinically overt bleeding: decrease in hemoglobin (hgb) of 2 g/dL or more or bleeding leading to transfusion or bleeding in a critical site or fatal bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.
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Timepoint [10]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [11]
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Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants
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Assessment method [11]
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Major Bleeding = acute, clinically overt bleeding: decrease in hemoglobin of 2 g/dL or more, or bleeding leading to transfusion, or bleeding in a critical site, or fatal bleeding. CRNM = acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. Minor =: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events were adjudicated by an ICAC blinded to treatment. Total bleeding = any of major, or CRNM, or minor bleeding. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of treated (received at least 1 dose of study drug).
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Timepoint [11]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [12]
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Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants
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Assessment method [12]
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Bleeding defined by International Society on Thrombosis and Haemostasis: CRNM defined as acute clinically overt bleeding: compromising hemodynamics, leading to hospitalization, hematoma, epistasis >5 minutes or repetitive, gingival bleeding, hematuria, macroscopic gastrointestinal hemorrhage, rectal blood loss, hemoptysis. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.
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Timepoint [12]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [13]
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Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants
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Assessment method [13]
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Bleeding defined by International Society on Thrombosis and Haemostasis: Minor bleeding: all acute clinically overt bleeding events not meeting the criteria for either major bleeding or CRNM. All events wre adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants) calculated as n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.
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Timepoint [13]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [14]
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Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants
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Assessment method [14]
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Bleeding defined by International Society on Thrombosis and Haemostasis: Total Bleeding defined as any of major, CRNM, or minor bleeding. All events were adjudicated by an ICAC blinded to treatment. Event rate (proportion of participants with event): n/N (n=number of participants with observation; N=Total number of participants in respective treatment group (all participants who received at least one dose of study drug). Participants were categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to the treatment received.
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Timepoint [14]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [15]
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants
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Assessment method [15]
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Treated Participants: all who received at least 1 dose of study drug. Participants categorized to the treatment group to which they were assigned unless incorrect study treatment was received throughout the study, in which case the participant was categorized according to treatment received. Included all SAEs and AEs with onset from first dose to last dose + 2 days (for AEs) or + 30 days (for SAEs); note; bleeding AEs and SAEs from first dose to last dose + 2 days included. Discontinuations due to AE included all AEs/SAEs from first dose until drug was discontinued. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Timepoint [15]
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First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued
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Secondary outcome [16]
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Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests
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Assessment method [16]
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Lower limit of normal (LLN). Upper limit of normal (ULN). Pre-therapy (PreRx). Absolute (Abs) neutrophil count, bands + neutrophils (ANC). Cells per microliter (c/µL). Grams per deciliter (g/dL). Cells per Liter (c/L). Millimeter (MM). White blood cells: < 0.75*LLN, > 1.25*ULN; Hemoglobin: <= 11.5 g/dL (males), <= 9.5 g/dL (females); Hematocrit: <= 37% (males), <= 32% (females); Erythrocytes: <0.75*10^6 c/µL*PreRx; Platelet count: < 75*10^9 c/L, > 700*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.750*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes> 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL, > 7.5*10^3 c/ µL.
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Timepoint [16]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [17]
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Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests
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Assessment method [17]
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Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if pre-dose < LLN then use < 0.75*pre-dose or > ULN if pre-dose > ULN then use > 1.25*pre-dose or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if pre-dose < LLN then use < 0.9*pre-dose or > ULN if pre-dose > ULN then use > 1.1*pre-dose or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if pre-dose < LLN then use < 0.95*pre-dose or > ULN if pre-dose > ULN then use > 1.05*pre-dose or < LLN.
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Timepoint [17]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [18]
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Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests
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Assessment method [18]
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Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL High: > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.
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Timepoint [18]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [19]
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Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests
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Assessment method [19]
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Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if pre-dose < LLN then use 0.9* pre-dose or > ULN if pre-dose > ULN then use 1.1 *pre-dose or <LLN; Uric acid High: > 1.5* ULN, or if pre-dose > ULN then use > 2 *pre-dose.
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Timepoint [19]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Secondary outcome [20]
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Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests
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Assessment method [20]
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All tests in urine: Glucose: If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4; Protein: If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4; Blood: If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4; Leukocyte esterase: If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4;Red blood cells (RBC): If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4; White blood cells (WBC): If missing pre-dose use = 2, or if value = 4, or if pre-dose = 0 or 0.5 use = 2, or if pre-dose = 1 use = 3, or if pre-dose = 2 or 3 use = 4.
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Timepoint [20]
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Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early)
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Eligibility
Key inclusion criteria
- Men and women = 18 years of age
- Clinical diagnosis of DVT or PE
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Contraindications for enoxaparin or warfarin
- Active bleeding or high risk for serious bleeding
- Short life expectancy
- Uncontrolled high blood pressure
- Significantly impaired kidney or liver function
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2013
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Sample size
Target
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Accrual to date
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Final
5614
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
0
0
Local Institution - Garran
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Recruitment hospital [2]
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Local Institution - Concord
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Recruitment hospital [3]
0
0
Local Institution - Kogarah
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Recruitment hospital [4]
0
0
Local Institution - Lismore
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Recruitment hospital [5]
0
0
Local Institution - Randwick
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Recruitment hospital [6]
0
0
Local Institution - Herston
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Recruitment hospital [7]
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Local Institution - Adelaide
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Recruitment hospital [8]
0
0
Local Institution - Bedford Park
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Recruitment hospital [9]
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0
Local Institution - Hobart
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Recruitment hospital [10]
0
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Local Institution - Box Hill
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Recruitment hospital [11]
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Local Institution - Clayton
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Recruitment hospital [12]
0
0
Local Institution - Ringwood East
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Recruitment hospital [13]
0
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Local Institution - Windsor
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Recruitment hospital [14]
0
0
Local Institution - Perth
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Recruitment postcode(s) [1]
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0
2605 - Garran
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Recruitment postcode(s) [2]
0
0
2139 - Concord
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Recruitment postcode(s) [3]
0
0
2217 - Kogarah
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Recruitment postcode(s) [4]
0
0
2480 - Lismore
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Recruitment postcode(s) [5]
0
0
2031 - Randwick
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Recruitment postcode(s) [6]
0
0
4029 - Herston
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Recruitment postcode(s) [7]
0
0
5000 - Adelaide
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Recruitment postcode(s) [8]
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0
5042 - Bedford Park
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Recruitment postcode(s) [9]
0
0
7000 - Hobart
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Recruitment postcode(s) [10]
0
0
3128 - Box Hill
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Recruitment postcode(s) [11]
0
0
3168 - Clayton
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Recruitment postcode(s) [12]
0
0
3135 - Ringwood East
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Recruitment postcode(s) [13]
0
0
3181 - Windsor
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Recruitment postcode(s) [14]
0
0
6001 - Perth
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
District of Columbia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Florida
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Georgia
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Illinois
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Indiana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Iowa
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Maine
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Michigan
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Mississippi
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Montana
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Nebraska
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Jersey
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
North Dakota
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Ohio
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Oregon
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Pennsylvania
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Utah
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Washington
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Santa Fe
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Cordoba
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Corrientes
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Graz
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Innsbruck
Query!
Country [38]
0
0
Austria
Query!
State/province [38]
0
0
Vienna
Query!
Country [39]
0
0
Austria
Query!
State/province [39]
0
0
Wien
Query!
Country [40]
0
0
Brazil
Query!
State/province [40]
0
0
Minas Gerais
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Parana
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Rio De Janeiro
Query!
Country [43]
0
0
Brazil
Query!
State/province [43]
0
0
Rio Grande Do Sul
Query!
Country [44]
0
0
Brazil
Query!
State/province [44]
0
0
Sao Paulo
Query!
Country [45]
0
0
Brazil
Query!
State/province [45]
0
0
SP
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Alberta
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
British Columbia
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Manitoba
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
New Brunswick
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Ontario
Query!
Country [51]
0
0
Canada
Query!
State/province [51]
0
0
Quebec
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Magallanes Antartica
Query!
Country [53]
0
0
Chile
Query!
State/province [53]
0
0
Metropolitana
Query!
Country [54]
0
0
Chile
Query!
State/province [54]
0
0
Valparaiso
Query!
Country [55]
0
0
China
Query!
State/province [55]
0
0
Beijing
Query!
Country [56]
0
0
China
Query!
State/province [56]
0
0
Guangdong
Query!
Country [57]
0
0
China
Query!
State/province [57]
0
0
Hubei
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Liaoning
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Shanghai
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Zhejiang
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Xian
Query!
Country [62]
0
0
Czech Republic
Query!
State/province [62]
0
0
Hradec Kralove
Query!
Country [63]
0
0
Czech Republic
Query!
State/province [63]
0
0
Kladno
Query!
Country [64]
0
0
Czech Republic
Query!
State/province [64]
0
0
Litomysl
Query!
Country [65]
0
0
Czech Republic
Query!
State/province [65]
0
0
Mestec Kralove
Query!
Country [66]
0
0
Czech Republic
Query!
State/province [66]
0
0
Ostrava Vitkovice
Query!
Country [67]
0
0
Czech Republic
Query!
State/province [67]
0
0
Ostrava
Query!
Country [68]
0
0
Czech Republic
Query!
State/province [68]
0
0
Praha 10
Query!
Country [69]
0
0
Czech Republic
Query!
State/province [69]
0
0
Praha 1
Query!
Country [70]
0
0
Czech Republic
Query!
State/province [70]
0
0
Praha 2
Query!
Country [71]
0
0
Czech Republic
Query!
State/province [71]
0
0
Usti Nad Labem
Query!
Country [72]
0
0
Czech Republic
Query!
State/province [72]
0
0
Usti Nad Orlici
Query!
Country [73]
0
0
Denmark
Query!
State/province [73]
0
0
Arhus C
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Hellerup
Query!
Country [75]
0
0
Denmark
Query!
State/province [75]
0
0
Herning
Query!
Country [76]
0
0
Denmark
Query!
State/province [76]
0
0
Hilleroed
Query!
Country [77]
0
0
Denmark
Query!
State/province [77]
0
0
Horsens
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Naestved
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Silkeborg
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Angers
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Arras
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Besancon
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Clamart
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Clermont-Ferrand Cedex 01
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Dijon
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Grenoble Cedex 9
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Langres Cedex
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Le Kremlin-Bicetre
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Lille Cedex
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Limoges Cedex
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Nantes
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Paris
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Pierre Benite
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Saint-Priest En Jarez
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Toulouse cedex 9
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Vernon
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Berlin
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Bochum
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Cologne
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Dortmund
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Dresden
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Frankfurt
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Gottingen
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Karlsbad
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Ludwigshafen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Mannheim
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Munchen
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Munich
Query!
Country [109]
0
0
Hong Kong
Query!
State/province [109]
0
0
Pokfulman
Query!
Country [110]
0
0
Hong Kong
Query!
State/province [110]
0
0
Shatin, N.T
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Budapest
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Gyula
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Kecskemet
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Miskolc
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Mosonmagyarovar
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Szekesfehervar
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Zalaegerszeg
Query!
Country [118]
0
0
India
Query!
State/province [118]
0
0
Andhra Pradesh
Query!
Country [119]
0
0
India
Query!
State/province [119]
0
0
Gujarat
Query!
Country [120]
0
0
India
Query!
State/province [120]
0
0
Haryana
Query!
Country [121]
0
0
India
Query!
State/province [121]
0
0
Karnataka
Query!
Country [122]
0
0
India
Query!
State/province [122]
0
0
Maharashtra
Query!
Country [123]
0
0
India
Query!
State/province [123]
0
0
Punjab
Query!
Country [124]
0
0
India
Query!
State/province [124]
0
0
Tagore Nagar
Query!
Country [125]
0
0
India
Query!
State/province [125]
0
0
Tamil Nadu
Query!
Country [126]
0
0
India
Query!
State/province [126]
0
0
Bangalore
Query!
Country [127]
0
0
India
Query!
State/province [127]
0
0
Pune
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Lower Galillee
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Afula
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Ashkelon
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
Hadera
Query!
Country [132]
0
0
Israel
Query!
State/province [132]
0
0
Haifa
Query!
Country [133]
0
0
Israel
Query!
State/province [133]
0
0
Holon
Query!
Country [134]
0
0
Israel
Query!
State/province [134]
0
0
Jerusalem
Query!
Country [135]
0
0
Israel
Query!
State/province [135]
0
0
Kfar Saba
Query!
Country [136]
0
0
Israel
Query!
State/province [136]
0
0
Nahariya
Query!
Country [137]
0
0
Israel
Query!
State/province [137]
0
0
Petach-Tikva
Query!
Country [138]
0
0
Israel
Query!
State/province [138]
0
0
Rehovot
Query!
Country [139]
0
0
Israel
Query!
State/province [139]
0
0
Safed
Query!
Country [140]
0
0
Israel
Query!
State/province [140]
0
0
Tel Aviv
Query!
Country [141]
0
0
Israel
Query!
State/province [141]
0
0
Tel Hashomer
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Bologna
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Castelfranco Veneto (Tv)
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Chieti Scalo
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Cosenza
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Milano
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Padova
Query!
Country [148]
0
0
Italy
Query!
State/province [148]
0
0
Palermo
Query!
Country [149]
0
0
Italy
Query!
State/province [149]
0
0
Pavia
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Piacenza
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Pisa
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Reggio Emilia
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Rome
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Rozzano (Mi)
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
San Daniele Del Friuli (Ud)
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Vicenza
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Vittorio Veneto (Tv)
Query!
Country [158]
0
0
Korea, Republic of
Query!
State/province [158]
0
0
Busan
Query!
Country [159]
0
0
Korea, Republic of
Query!
State/province [159]
0
0
Seoul
Query!
Country [160]
0
0
Malaysia
Query!
State/province [160]
0
0
Penang
Query!
Country [161]
0
0
Malaysia
Query!
State/province [161]
0
0
Perak
Query!
Country [162]
0
0
Malaysia
Query!
State/province [162]
0
0
Kuala Lumpur
Query!
Country [163]
0
0
Malaysia
Query!
State/province [163]
0
0
Melaka
Query!
Country [164]
0
0
Mexico
Query!
State/province [164]
0
0
Baja California
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Guanajuato
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Jalisco
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Nuevo Leon
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
Veracruz
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Aguascalientes
Query!
Country [170]
0
0
Mexico
Query!
State/province [170]
0
0
Durango
Query!
Country [171]
0
0
Norway
Query!
State/province [171]
0
0
Alesund
Query!
Country [172]
0
0
Norway
Query!
State/province [172]
0
0
Fredrikstad
Query!
Country [173]
0
0
Norway
Query!
State/province [173]
0
0
Gjettum
Query!
Country [174]
0
0
Norway
Query!
State/province [174]
0
0
Gjovik
Query!
Country [175]
0
0
Norway
Query!
State/province [175]
0
0
Hamar
Query!
Country [176]
0
0
Norway
Query!
State/province [176]
0
0
Oslo
Query!
Country [177]
0
0
Norway
Query!
State/province [177]
0
0
Trondheim
Query!
Country [178]
0
0
Norway
Query!
State/province [178]
0
0
Tynset
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Bialystok
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Bydgoszcz
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Gdansk
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Gdynia
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Lodz
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Lublin
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Poznan
Query!
Country [186]
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0
Poland
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State/province [186]
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0
Przeworsk
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Country [187]
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0
Poland
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State/province [187]
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0
Szczecin
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Country [188]
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0
Poland
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State/province [188]
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0
Warsawa
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Country [189]
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0
Poland
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State/province [189]
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Warsaw
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Country [190]
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0
Poland
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State/province [190]
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0
Warszawa
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Country [191]
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0
Poland
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State/province [191]
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Wroclaw
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Country [192]
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0
Portugal
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State/province [192]
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Coimbra
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Country [193]
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Portugal
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State/province [193]
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0
Guarda
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Country [194]
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Portugal
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State/province [194]
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0
Lisboa
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Country [195]
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0
Puerto Rico
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State/province [195]
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San Juan
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Country [196]
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0
Romania
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State/province [196]
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0
Baia Mare
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Country [197]
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Romania
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State/province [197]
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Bucharest
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Country [198]
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Romania
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State/province [198]
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0
Targu Mures
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Country [199]
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Russian Federation
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State/province [199]
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Arkhangelsk
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Country [200]
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Russian Federation
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State/province [200]
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0
Chelyabinsk
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Country [201]
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0
Russian Federation
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State/province [201]
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Kazan
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Country [202]
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0
Russian Federation
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State/province [202]
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Moscow
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Country [203]
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Russian Federation
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State/province [203]
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Novosibirsk
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Country [204]
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Russian Federation
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State/province [204]
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Rostov-On Don
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Country [205]
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Russian Federation
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State/province [205]
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Ryazan
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Country [206]
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0
Russian Federation
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State/province [206]
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0
Saint Petersburg
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Country [207]
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0
Russian Federation
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State/province [207]
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0
Saint-Petersburg
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Country [208]
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0
Russian Federation
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State/province [208]
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0
Saratov
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Country [209]
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0
Russian Federation
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State/province [209]
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0
St Petersburg
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Country [210]
0
0
Russian Federation
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State/province [210]
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0
Yaroslavl
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Country [211]
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0
Singapore
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State/province [211]
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Singapore
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Country [212]
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South Africa
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State/province [212]
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Free State
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Country [213]
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South Africa
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State/province [213]
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Gauteng
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Country [214]
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South Africa
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State/province [214]
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Kwa Zulu Natal
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Country [215]
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South Africa
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State/province [215]
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Western Cape
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Country [216]
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0
Spain
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State/province [216]
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0
Alicante
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Country [217]
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Spain
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State/province [217]
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0
Getafe
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Country [218]
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0
Spain
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State/province [218]
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0
L'Hospitalet De Llobregat
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Country [219]
0
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Spain
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State/province [219]
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Leon
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Country [220]
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0
Spain
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State/province [220]
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0
Madrid
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Country [221]
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0
Spain
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State/province [221]
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Malaga
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Country [222]
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Spain
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State/province [222]
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Mourente
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Country [223]
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Spain
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State/province [223]
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Tarragona
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Country [224]
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Ukraine
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State/province [224]
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Chernihiv
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Country [225]
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0
Ukraine
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State/province [225]
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0
Dnipropetrovsk
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Country [226]
0
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Ukraine
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State/province [226]
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0
Donetsk
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Country [227]
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Ukraine
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State/province [227]
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0
Ivano-Frankivsk
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Country [228]
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0
Ukraine
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State/province [228]
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Kharkiv
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Country [229]
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Ukraine
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State/province [229]
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Kyiv
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Country [230]
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0
Ukraine
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State/province [230]
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Lviv
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Country [231]
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Ukraine
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State/province [231]
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0
Odesa
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Country [232]
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0
Ukraine
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State/province [232]
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0
Ternopil
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Country [233]
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0
Ukraine
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State/province [233]
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0
Vinnytsia
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Country [234]
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Ukraine
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State/province [234]
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0
Zaporizhzhia
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Country [235]
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0
United Kingdom
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State/province [235]
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0
West Lothian
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
Pfizer
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Address [1]
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0
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the effects of an investigational blood thinner,
apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep
vein thrombosis (DVT) or pulmonary embolism (PE)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00643201
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00643201
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