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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/NCT00457002
Registration number
NCT00457002
Ethics application status
Date submitted
4/04/2007
Date registered
5/04/2007
Date last updated
8/12/2015
Titles & IDs
Public title
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
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Scientific title
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
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Secondary ID [1]
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CV185-036
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Universal Trial Number (UTN)
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Trial acronym
ADOPT
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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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Pulmonary Embolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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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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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Enoxaparin
Experimental: Arm 1 - While hospitalized, Apixaban plus Placebo
Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC)
After hospital discharge, Apixaban
Apixaban (Tablets, Oral, 2.5 mg)
Active Comparator: Arm 2 - While hospitalized, Enoxaparin plus Placebo
Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral)
After hospital discharge: Placebo
Placebo (Tablets, Oral)
Treatment: Drugs: Apixaban
Apixaban: Twice daily, 30 days
Placebo: Once daily, 6-14 days
Treatment: Drugs: Enoxaparin
Enoxaparin: Once daily, 6-14 days
Placebo: Twice daily, 30 days
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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 Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
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Assessment method [1]
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VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause. Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC). Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [1]
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Intended Treatment Period
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Primary outcome [2]
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Incidence of Major Bleeding During the Treatment Period in Treated Participants
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Assessment method [2]
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Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [2]
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Day 1, first dose of study drug, to last dose of study drug plus 2 days
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Primary outcome [3]
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Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
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Assessment method [3]
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Bleeding was adjudicated by an ICAC using criteria from the ISTH. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [3]
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Day 1, first dose of study drug, to last dose of study drug plus 2 days
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Primary outcome [4]
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Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
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Assessment method [4]
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Bleeding was adjudicated by an ICAC using criteria from the ISTH. Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal. CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss. Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs. Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [4]
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Day 1, first dose of study drug, to last dose of study drug plus 2 days
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Primary outcome [5]
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Incidence of All Bleeding During the Treatment Period in Treated Participants
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Assessment method [5]
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Bleeding was adjudicated by an ICAC using criteria from the ISTH. Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [5]
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Day 1, first dose of drug to last dose of drug plus 2 days
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Secondary outcome [1]
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Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
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Assessment method [1]
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Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
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Timepoint [1]
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Day 1 to last dose of parenteral study drug plus 1 day
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Secondary outcome [2]
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Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
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Assessment method [2]
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Parenteral study drug=active or placebo enoxaparin. Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug. Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
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Timepoint [2]
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Day 1 to last dose of parenteral study drug plus 1 day
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Secondary outcome [3]
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Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [3]
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Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. All-Cause Death (A-C Death). Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [3]
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Intended Treatment Period
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Secondary outcome [4]
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Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [4]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [4]
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Intended Treatment Period
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Secondary outcome [5]
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Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
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Assessment method [5]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [5]
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Intended Treatment Period
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Secondary outcome [6]
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Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
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Assessment method [6]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [6]
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Intended Treatment Period
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Secondary outcome [7]
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Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [7]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [7]
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Intended Treatment Period
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Secondary outcome [8]
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Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
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Assessment method [8]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [8]
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Intended Treatment Period
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Secondary outcome [9]
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Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
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Assessment method [9]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound. VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [9]
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Intended Treatment Period
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Secondary outcome [10]
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Incidence of Adjudicated PE With Onset During the Intended Treatment Period
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Assessment method [10]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. PE: non-fatal or fatal. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [10]
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Intended Treatment Period
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Secondary outcome [11]
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Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
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Assessment method [11]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [11]
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Intended Treatment Period
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Secondary outcome [12]
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Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
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Assessment method [12]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [12]
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Intended Treatment Period
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Secondary outcome [13]
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Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
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Assessment method [13]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [13]
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Intended Treatment Period
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Secondary outcome [14]
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Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
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Assessment method [14]
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Events were adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [14]
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Intended Treatment Period
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Secondary outcome [15]
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Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
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Assessment method [15]
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Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [15]
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Intended Treatment Period
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Secondary outcome [16]
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Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
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Assessment method [16]
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A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior. CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time. Events adjudicated by ICAC. Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
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Timepoint [16]
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Intended Treatment Period
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Secondary outcome [17]
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Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
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Assessment method [17]
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Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.
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Timepoint [17]
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Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
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Secondary outcome [18]
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Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
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Assessment method [18]
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Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.
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Timepoint [18]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [19]
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Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
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Assessment method [19]
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Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.
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Timepoint [19]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [20]
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Mean Change From Baseline in Heart Rate in Treated Participants
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Assessment method [20]
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Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days. Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.
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Timepoint [20]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [21]
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Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
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Assessment method [21]
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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). Absolute (Abs). Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL. Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
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Timepoint [21]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [22]
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Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
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Assessment method [22]
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Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
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Timepoint [22]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [23]
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Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
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Assessment method [23]
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Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L). BUN mg/dL > 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. Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
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Timepoint [23]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [24]
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Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
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Assessment method [24]
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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 PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx. Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx. Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.
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Timepoint [24]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [25]
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Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
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Assessment method [25]
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Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke. Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants). Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.
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Timepoint [25]
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Day 1 to last dose of study drug plus 2 days
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Secondary outcome [26]
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Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
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Assessment method [26]
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Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs. Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.
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Timepoint [26]
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Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
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Secondary outcome [27]
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Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
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Assessment method [27]
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Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL. Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.
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Timepoint [27]
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Day 1 to last dose of study drug plus 2 days
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Eligibility
Key inclusion criteria
- men and non-pregnant, non-breastfeeding women
- 40 years or older
- hospitalized with congestive heart failure or acute respiratory failure
- infection (without septic shock)
- acute rheumatic disorder
- inflammatory bowel disease
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- patients with venous thromboembolism (VTE)
- active bleeding or at high risk of bleeding
- unable to take oral medication
- with diseases requiring ongoing treatment with anticoagulants or antiplatelets other
than aspirin at a dose = 165 mg/day.
Query!
Study design
Purpose of the study
Prevention
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/06/2007
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/05/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
6758
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Local Institution - Concord
Query!
Recruitment hospital [2]
0
0
Local Institution - St Leonards
Query!
Recruitment hospital [3]
0
0
Local Institution - Kippa Ring
Query!
Recruitment hospital [4]
0
0
Local Institution - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Local Institution - Bedford Park
Query!
Recruitment hospital [6]
0
0
Local Institution - Woodville
Query!
Recruitment hospital [7]
0
0
Local Institution - Box Hill
Query!
Recruitment hospital [8]
0
0
Local Institution - Parkville
Query!
Recruitment hospital [9]
0
0
Local Institution - Ringwood East
Query!
Recruitment postcode(s) [1]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [2]
0
0
2065 - St Leonards
Query!
Recruitment postcode(s) [3]
0
0
4021 - Kippa Ring
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [6]
0
0
5011 - Woodville
Query!
Recruitment postcode(s) [7]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [8]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [9]
0
0
3135 - Ringwood East
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
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
Idaho
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Illinois
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Indiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kansas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
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
Missouri
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Montana
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oklahoma
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Texas
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Utah
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Virginia
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Buenos Aires
Query!
Country [29]
0
0
Argentina
Query!
State/province [29]
0
0
Santa Fe
Query!
Country [30]
0
0
Argentina
Query!
State/province [30]
0
0
Tucuman
Query!
Country [31]
0
0
Argentina
Query!
State/province [31]
0
0
Cordoba
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Corrientes
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Graz
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Wien
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Waals-Brabant
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Antwerpen
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Brasschaat
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Bruxelles
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Huy
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Leuven
Query!
Country [41]
0
0
Brazil
Query!
State/province [41]
0
0
Minas Gerais
Query!
Country [42]
0
0
Brazil
Query!
State/province [42]
0
0
Parana
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
Canada
Query!
State/province [45]
0
0
Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Quebec
Query!
Country [47]
0
0
Chile
Query!
State/province [47]
0
0
Araucania
Query!
Country [48]
0
0
Chile
Query!
State/province [48]
0
0
Metropolitana
Query!
Country [49]
0
0
Chile
Query!
State/province [49]
0
0
Valparaiso
Query!
Country [50]
0
0
Colombia
Query!
State/province [50]
0
0
Bogota
Query!
Country [51]
0
0
Colombia
Query!
State/province [51]
0
0
Bucaramanga
Query!
Country [52]
0
0
Colombia
Query!
State/province [52]
0
0
Medellin
Query!
Country [53]
0
0
Czech Republic
Query!
State/province [53]
0
0
Brno
Query!
Country [54]
0
0
Czech Republic
Query!
State/province [54]
0
0
Jindrichuv Hradec
Query!
Country [55]
0
0
Czech Republic
Query!
State/province [55]
0
0
Kladno
Query!
Country [56]
0
0
Czech Republic
Query!
State/province [56]
0
0
Kyjov
Query!
Country [57]
0
0
Czech Republic
Query!
State/province [57]
0
0
Ostrava
Query!
Country [58]
0
0
Czech Republic
Query!
State/province [58]
0
0
Prague 2
Query!
Country [59]
0
0
Czech Republic
Query!
State/province [59]
0
0
Praha 1
Query!
Country [60]
0
0
Czech Republic
Query!
State/province [60]
0
0
Praha 5
Query!
Country [61]
0
0
Czech Republic
Query!
State/province [61]
0
0
Usti Nad Labem
Query!
Country [62]
0
0
Denmark
Query!
State/province [62]
0
0
Aalborg
Query!
Country [63]
0
0
Denmark
Query!
State/province [63]
0
0
Aarhus N
Query!
Country [64]
0
0
Denmark
Query!
State/province [64]
0
0
Arhus C
Query!
Country [65]
0
0
Denmark
Query!
State/province [65]
0
0
Frederiksberg
Query!
Country [66]
0
0
Denmark
Query!
State/province [66]
0
0
Glostrup
Query!
Country [67]
0
0
Denmark
Query!
State/province [67]
0
0
Hellerup
Query!
Country [68]
0
0
Denmark
Query!
State/province [68]
0
0
Herlev
Query!
Country [69]
0
0
Denmark
Query!
State/province [69]
0
0
Herning
Query!
Country [70]
0
0
Denmark
Query!
State/province [70]
0
0
Hvidovre
Query!
Country [71]
0
0
Denmark
Query!
State/province [71]
0
0
Odense
Query!
Country [72]
0
0
Denmark
Query!
State/province [72]
0
0
Randers No
Query!
Country [73]
0
0
Denmark
Query!
State/province [73]
0
0
Silkeborg
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Bordeaux
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Brest Cedex
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Brest
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Dijon Cedex
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Grenoble Cedex 9
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Lille Cedex
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Nancy
Query!
Country [81]
0
0
France
Query!
State/province [81]
0
0
Nimes Cedex 9
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Paris Cedex 10
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Paris Cedex 15
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Saint Etienne Cedex 02
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Vernon
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Bonn
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Coburg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Darmstadt
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Dresden
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Hannover
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Karlsbad
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Luebeck
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Mannheim
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Offenbach
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Witten
Query!
Country [96]
0
0
Hong Kong
Query!
State/province [96]
0
0
Shatin, N.T.
Query!
Country [97]
0
0
Hungary
Query!
State/province [97]
0
0
Budapest
Query!
Country [98]
0
0
Hungary
Query!
State/province [98]
0
0
Debrecen
Query!
Country [99]
0
0
Hungary
Query!
State/province [99]
0
0
Dunaujvaros
Query!
Country [100]
0
0
Hungary
Query!
State/province [100]
0
0
Eger
Query!
Country [101]
0
0
India
Query!
State/province [101]
0
0
Andhra-Pradesh
Query!
Country [102]
0
0
India
Query!
State/province [102]
0
0
Andra Pradesh
Query!
Country [103]
0
0
India
Query!
State/province [103]
0
0
Gujarat
Query!
Country [104]
0
0
India
Query!
State/province [104]
0
0
Karnataka
Query!
Country [105]
0
0
India
Query!
State/province [105]
0
0
Madhya Pardesh
Query!
Country [106]
0
0
India
Query!
State/province [106]
0
0
Maharashtra
Query!
Country [107]
0
0
India
Query!
State/province [107]
0
0
Maharastra
Query!
Country [108]
0
0
India
Query!
State/province [108]
0
0
Punjab
Query!
Country [109]
0
0
India
Query!
State/province [109]
0
0
Tamil Nadu
Query!
Country [110]
0
0
India
Query!
State/province [110]
0
0
Tamil-Nadu
Query!
Country [111]
0
0
India
Query!
State/province [111]
0
0
Uttar Pradesh
Query!
Country [112]
0
0
India
Query!
State/province [112]
0
0
Ahmedabad
Query!
Country [113]
0
0
India
Query!
State/province [113]
0
0
Bangalore
Query!
Country [114]
0
0
India
Query!
State/province [114]
0
0
Hyderabad
Query!
Country [115]
0
0
India
Query!
State/province [115]
0
0
Mumbai
Query!
Country [116]
0
0
India
Query!
State/province [116]
0
0
New Delhi
Query!
Country [117]
0
0
Israel
Query!
State/province [117]
0
0
Afula
Query!
Country [118]
0
0
Israel
Query!
State/province [118]
0
0
Ashkelon
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
Beer Sheva
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Haifa
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Petach Tikva
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
Safed
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Tel Hashomer
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Tel-Aviv
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
Zerifin
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Chieti Scalo
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Cremona
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Padua
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Piacenza
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Reggio Emilia
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Treviso
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Vicenza
Query!
Country [133]
0
0
Korea, Republic of
Query!
State/province [133]
0
0
Gyeonggi-Do
Query!
Country [134]
0
0
Korea, Republic of
Query!
State/province [134]
0
0
Seoul
Query!
Country [135]
0
0
Korea, Republic of
Query!
State/province [135]
0
0
Suwon
Query!
Country [136]
0
0
Malaysia
Query!
State/province [136]
0
0
Kelantan
Query!
Country [137]
0
0
Malaysia
Query!
State/province [137]
0
0
Selangor
Query!
Country [138]
0
0
Malaysia
Query!
State/province [138]
0
0
Johor Bahru
Query!
Country [139]
0
0
Mexico
Query!
State/province [139]
0
0
Distrito Federal
Query!
Country [140]
0
0
Mexico
Query!
State/province [140]
0
0
Nuevo Leon
Query!
Country [141]
0
0
Mexico
Query!
State/province [141]
0
0
Veracruz
Query!
Country [142]
0
0
Mexico
Query!
State/province [142]
0
0
Yucatan
Query!
Country [143]
0
0
Mexico
Query!
State/province [143]
0
0
Queretaro
Query!
Country [144]
0
0
Mexico
Query!
State/province [144]
0
0
San Luis Potosi
Query!
Country [145]
0
0
Netherlands
Query!
State/province [145]
0
0
Den Helder
Query!
Country [146]
0
0
Norway
Query!
State/province [146]
0
0
Kongsvinger
Query!
Country [147]
0
0
Peru
Query!
State/province [147]
0
0
Lima
Query!
Country [148]
0
0
Peru
Query!
State/province [148]
0
0
Arequipa
Query!
Country [149]
0
0
Peru
Query!
State/province [149]
0
0
Callao
Query!
Country [150]
0
0
Philippines
Query!
State/province [150]
0
0
Misamis Oriental
Query!
Country [151]
0
0
Philippines
Query!
State/province [151]
0
0
Las Pinas
Query!
Country [152]
0
0
Philippines
Query!
State/province [152]
0
0
Quezon City
Query!
Country [153]
0
0
Poland
Query!
State/province [153]
0
0
Bydgoszcz
Query!
Country [154]
0
0
Poland
Query!
State/province [154]
0
0
Krakow
Query!
Country [155]
0
0
Poland
Query!
State/province [155]
0
0
Lodz
Query!
Country [156]
0
0
Poland
Query!
State/province [156]
0
0
Nowa Sol
Query!
Country [157]
0
0
Poland
Query!
State/province [157]
0
0
Poznan
Query!
Country [158]
0
0
Poland
Query!
State/province [158]
0
0
Skierniewice
Query!
Country [159]
0
0
Poland
Query!
State/province [159]
0
0
Warszawa
Query!
Country [160]
0
0
Poland
Query!
State/province [160]
0
0
Wejherowo
Query!
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Poland
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Zielona Gora
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Russian Federation
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Moscow
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Russian Federation
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State/province [163]
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Odintsovo
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Russian Federation
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Podolsk
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Russian Federation
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Ryazan
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Russian Federation
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Saint Petersburg
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Russian Federation
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Russian Federation
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Saratov
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Russian Federation
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St Petersburg
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Russian Federation
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St. Petersburg
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Russian Federation
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St.Petersburg
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Singapore
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Singapore
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South Africa
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Free State
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South Africa
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Gauteng
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South Africa
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Kwa Zulu Natal
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South Africa
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Western Cape
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South Africa
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Groenkloof
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Spain
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Alicante
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Spain
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Alcorcon(Madrid)
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Tarragona
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Sweden
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Goteborg
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Sweden
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Lund
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Taiwan
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Tainan
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Taiwan
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Taichung
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Turkey
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Capa
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Turkey
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Dikimevi
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Turkey
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Istanbul
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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Ukraine
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Kyiv
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Ukraine
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Lutsk
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Ukraine
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Lviv
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Ukraine
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Uzhgorod
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Ukraine
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Vinnitsa
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United Kingdom
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Greater London
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United Kingdom
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Middlesex
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United Kingdom
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Tyne And Wear
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United Kingdom
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West Midlands
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United Kingdom
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Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Summary
Brief summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep
vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within
patients hospitalized for acute medical illness, and to learn how apixaban compares to
enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be
studied.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00457002
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00457002
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