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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/NCT00440193
Registration number
NCT00440193
Ethics application status
Date submitted
23/02/2007
Date registered
26/02/2007
Date last updated
27/02/2014
Titles & IDs
Public title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep Vein Thrombosis - The EINSTEIN DVT Study
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Scientific title
Oral Direct Factor Xa Inhibitor Rivaroxaban in Patients With Acute Symptomatic Deep-Vein Thrombosis or Pulmonary Embolism
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Secondary ID [1]
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2006-004495-13
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Secondary ID [2]
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11702a
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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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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cardiovascular
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Other cardiovascular diseases
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Blood
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Enoxaparin followed by VKA
Experimental: Rivaroxaban (Xarelto, BAY59-7939) - Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
Active Comparator: Enoxaparin/VKA - Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food.
Treatment: Drugs: Enoxaparin followed by VKA
Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.
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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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Percentage of Participants With Symptomatic Recurrent Venous Thromboembolism [VTE] (i.e. the Composite of Recurrent Deep Vein Thrombosis [DVT] or Fatal or Non-fatal Pulmonary Embolism [PE]) Until the Intended End of Study Treatment
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Assessment method [1]
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All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for fatal PE) or unexplained death for which DVT/PE could not be ruled out (for fatal PE), and/or case summaries.
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Timepoint [1]
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3-, 6- or 12-month study treatment period
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Secondary outcome [1]
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Percentage of Participants With the Composite Variable Comprising Recurrent DVT, Non-fatal PE and All Cause Mortality Until the Intended End of Study Treatment
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Assessment method [1]
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All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound (for DVT), venography (for DVT), spiral computed tomography (CT) scanning (for PE), pulmonary angiography (for PE), ventilation/perfusion lung scan (for PE), lung scintigraphy (for PE), autopsy (for deaths), results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [1]
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3-, 6- or 12-month study treatment period
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Secondary outcome [2]
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Percentage of Participants With an Event for Net Clinical Benefit 1 Until the Intended End of Study Treatment
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Assessment method [2]
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Net clinical benefit 1: composite of recurrent DVT or non-fatal or fatal PE, and major bleeding. Major bleeding was overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of =2 units, occurring in a critical site or contributing to death. Net clinical benefit was considered greater in those participants with fewer composite events. All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment, based on either compression ultrasound, venography, spiral computed tomography scanning, pulmonary angiography, ventilation/perfusion lung scan, lung scintigraphy, autopsy or unexplained death for which DVT/PE could not be ruled out, results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [2]
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3-, 6- or 12-month study treatment period
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Secondary outcome [3]
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Percentage of Participants With Recurrent DVT Until the Intended End of Study Treatment
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Assessment method [3]
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All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either compression ultrasound, venography, results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [3]
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3-, 6- or 12-month study treatment period
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Secondary outcome [4]
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Percentage of Participants With Clinically Relevant Bleeding, Treatment-emergent (Time Window: Until 2 Days After Last Dose)
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Assessment method [4]
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All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Clinically relevant bleeding included major bleeding (overt bleeding associated with 2 g/dL or greater fall in hemoglobin, leading to a transfusion of 2 or more units of packed red blood cells or whole blood, occurring in a critical site or contributing to death) and non-major bleeding associated with medical intervention, unscheduled physician contact, (temporary) cessation of study treatment, discomfort for the participants such as pain, or impairment of activities of daily life.
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Timepoint [4]
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3-, 6- or 12-month study treatment period
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Secondary outcome [5]
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Percentage of Participants With All Deaths
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Assessment method [5]
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All events were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based on either autopsy, results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [5]
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3-, 6- or 12-month study treatment period
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Secondary outcome [6]
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Percentage of Participants With Other Vascular Events, On-treatment (Time Window: Until 1 Day After Last Dose)
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Assessment method [6]
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All pre-defined vascular events (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack, non-central nervous system systemic embolism or vascular death) were adjudicated and confirmed by a central independent adjudication committee blinded to treatment. Events were assessed based results/films/images of confirmatory testing, and/or case summaries.
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Timepoint [6]
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3-, 6- or 12-month study treatment period
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Eligibility
Key inclusion criteria
- Confirmed acute symptomatic proximal DVT without symptomatic 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
- Legal lower age limitations (country specific)
- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
current episode of DVT and/or PE
- Other indication for VKA than DVT and/or PE
- The pre-randomization anti-coagulant treatment (Criteria # 4) has been prolonged from
36 hours to a maximum of 48 hours.
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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
Open (masking not used)
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Who is / are masked / blinded?
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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
1/03/2007
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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
1/04/2010
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Sample size
Target
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Accrual to date
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Final
3449
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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- Garran
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Recruitment hospital [2]
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- Darlinghurst
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- Gosford
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- Kogarah
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Recruitment hospital [5]
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- Lismore
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- St Leonards
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- Sydney
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- Brisbane
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- Redcliffe
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- Southport
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Recruitment hospital [11]
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- Woolloongabba
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- Adelaide
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Recruitment hospital [13]
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- Woodville South
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Recruitment hospital [14]
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- Box Hill
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- Clayton
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- Geelong
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- Melbourne
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Recruitment hospital [18]
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- Fremantle
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Recruitment hospital [19]
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- Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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2217 - Kogarah
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Recruitment postcode(s) [5]
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2480 - Lismore
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Recruitment postcode(s) [6]
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2065 - St Leonards
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Recruitment postcode(s) [7]
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2031 - Sydney
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Recruitment postcode(s) [8]
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2139 - Sydney
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Recruitment postcode(s) [9]
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2229 - Sydney
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Recruitment postcode(s) [10]
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4029 - Brisbane
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Recruitment postcode(s) [11]
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4020 - Redcliffe
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Recruitment postcode(s) [12]
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4215 - Southport
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Recruitment postcode(s) [13]
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4102 - Woolloongabba
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Recruitment postcode(s) [14]
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5042 - Adelaide
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Recruitment postcode(s) [15]
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5011 - Woodville South
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Recruitment postcode(s) [16]
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3128 - Box Hill
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Recruitment postcode(s) [17]
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3168 - Clayton
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Recruitment postcode(s) [18]
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3220 - Geelong
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Recruitment postcode(s) [19]
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3135 - Melbourne
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Recruitment postcode(s) [20]
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3181 - Melbourne
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Recruitment postcode(s) [21]
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6160 - Fremantle
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Recruitment postcode(s) [22]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Florida
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United States of America
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Idaho
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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New Mexico
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United States of America
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North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Texas
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Utah
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United States of America
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Virginia
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United States of America
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Washington
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Austria
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Steiermark
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Vorarlberg
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Innsbruck
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Bruxelles - Brussel
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Prague 5
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Aarhus C
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Braedstrup
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Hellerup
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Seinäjoki
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Agen Cedex 9
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France
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Angers Cedex 01
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Arras
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Besancon
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Castelnau Le Lez
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Clamart
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Nantes
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Nice
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Nimes Cedex 9
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Orthez
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Paris
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France
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Pierre Benite
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Roanne
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Rouen Cedex
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Saint Etienne
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Tours
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France
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Vandoeuvre Les Nancy
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France
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Vernon
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Germany
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Baden-Württemberg
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Germany
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Germany
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India
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Israel
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Israel
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Israel
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Israel
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Rehovot
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Israel
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Safed
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Israel
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Tel Aviv
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Italy
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Italy
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Italy
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Italy
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Italy
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Italy
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Pavia
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Italy
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Piacenza
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Italy
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Reggio Emilia
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Italy
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Italy
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Enschede
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Rud
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Thailand
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Pathumwan, Bangkok
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Greater London
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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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]
0
0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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0
0
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority
program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with
confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT00440193
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Public notes
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Contacts
Principal investigator
Name
0
0
Bayer Study Director
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Bayer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00440193
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