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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/NCT02064439
Registration number
NCT02064439
Ethics application status
Date submitted
14/02/2014
Date registered
17/02/2014
Date last updated
19/12/2017
Titles & IDs
Public title
Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism)
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Scientific title
Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism
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Secondary ID [1]
0
0
2013-000619-26
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Secondary ID [2]
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0
16416
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Universal Trial Number (UTN)
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Trial acronym
EinsteinChoice
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism
0
0
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Thromboembolism
0
0
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Thrombosis
0
0
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Venous Thrombosis
0
0
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Venous Thromboembolism
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
0
0
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Clotting disorders
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Respiratory
0
0
0
0
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Other respiratory disorders / diseases
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Cardiovascular
0
0
0
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 - BAY 59-7939
Treatment: Drugs - BAY 59-7939
Treatment: Drugs - ASA
Experimental: Arm 1 - Rivaroxaban 10 mg once daily for 12 months
Experimental: Arm 2 - Rivaroxaban 20 mg once daily for 12 months
Active Comparator: Arm 3 - ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
Treatment: Drugs: BAY 59-7939
10 mg tablet once daily for 12 months
Treatment: Drugs: BAY 59-7939
20 mg tablet once daily for 12 months
Treatment: Drugs: ASA
100 mg tablet once daily for 12 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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Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
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Assessment method [1]
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The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.
Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
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Timepoint [1]
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Up to 12 months, at least 6 months
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Primary outcome [2]
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Number of Participants With First Treatment-emergent Major Bleeding
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Assessment method [2]
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The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.
Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
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Timepoint [2]
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Up to 12 months, at least 6 months
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Secondary outcome [1]
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Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
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Assessment method [1]
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The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
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Timepoint [1]
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Up to 12 months, at least 6 months
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Secondary outcome [2]
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Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
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Assessment method [2]
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The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
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Timepoint [2]
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Up to 12 months, at least 6 months
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Eligibility
Key inclusion criteria
- Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12
months and did not interrupt anticoagulation for longer than 1 week
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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) Indication for therapeutic-dosed
anticoagulants Indication for antiplatelet therapy or a conventional non-steroid
anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy
leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30
mL/min
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Study design
Purpose of the study
Prevention
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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 administering the treatment/s
The people assessing the outcomes
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
5/03/2014
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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
4/11/2016
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Sample size
Target
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Accrual to date
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Final
3365
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
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Recruitment hospital [1]
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- Garran
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- Concord
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- Kogarah
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- Lismore
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- Randwick
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- St Leonards
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- Westmead
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- Brisbane
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- Clayton
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- Box Hill
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Recruitment hospital [11]
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- Melbourne
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Recruitment hospital [12]
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- Redcliffe
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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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2139 - Concord
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Recruitment postcode(s) [3]
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2217 - Kogarah
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Recruitment postcode(s) [4]
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2480 - Lismore
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Recruitment postcode(s) [5]
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2031 - Randwick
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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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2145 - Westmead
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Recruitment postcode(s) [8]
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4029 - Brisbane
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Recruitment postcode(s) [9]
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3168 - Clayton
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Recruitment postcode(s) [10]
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3128 - Box Hill
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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4020 - Redcliffe
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Illinois
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Maine
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Massachusetts
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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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Veneto
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Korea, Republic of
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Gwangju Gwang''yeogsi
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Mexico
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Mexico
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Jalisco
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Mexico
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Mexico
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Assen
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Poznan
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Poland
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Poland
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Russian Federation
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Barnaul
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Russian Federation
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Ryazan
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Russian Federation
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Sochi
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Russian Federation
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St. Petersburg
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Russian Federation
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Tver
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Gauteng
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Western Cape
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Alicante
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Taiwan
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Taiwan
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Taiwan
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Taipei
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Istanbul
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Devon
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Humberside
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United Kingdom
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Tyne And Wear
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Cardiff
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London
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Ha Noi
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bayer
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Other collaborator category [1]
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Commercial sector/Industry
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Janssen Scientific Affairs, LLC
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Ethics approval
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Summary
Brief summary
This is a multicenter, randomized, double-blind, event-driven, superiority study for
efficacy.
Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who
completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02064439
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Trial related presentations / publications
Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.
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Public notes
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Contacts
Principal investigator
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Bayer Study Director
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Bayer
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02064439
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