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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
2013-000619-26
Secondary ID [2] 0 0
16416
Universal Trial Number (UTN)
Trial acronym
EinsteinChoice
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Thromboembolism 0 0
Thrombosis 0 0
Venous Thrombosis 0 0
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 12 months, at least 6 months
Primary outcome [2] 0 0
Number of Participants With First Treatment-emergent Major Bleeding
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 12 months, at least 6 months
Secondary outcome [1] 0 0
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 12 months, at least 6 months
Secondary outcome [2] 0 0
Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to 12 months, at least 6 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/03/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2016
Sample size
Target
Accrual to date
Final
3365
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Garran
Recruitment hospital [2] 0 0
- Concord
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Lismore
Recruitment hospital [5] 0 0
- Randwick
Recruitment hospital [6] 0 0
- St Leonards
Recruitment hospital [7] 0 0
- Westmead
Recruitment hospital [8] 0 0
- Brisbane
Recruitment hospital [9] 0 0
- Clayton
Recruitment hospital [10] 0 0
- Box Hill
Recruitment hospital [11] 0 0
- Melbourne
Recruitment hospital [12] 0 0
- Redcliffe
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2480 - Lismore
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4029 - Brisbane
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
3128 - Box Hill
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
4020 - Redcliffe
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Colorado
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Massachusetts
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Washington
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Austria
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Steiermark
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Wien
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Hasselt
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Leuven
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Prague
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Praha 1
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Praha 5
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Usti nad Labem
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Aarhus N
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Copenhagen
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Glostrup
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Hellerup
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Herning
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Svendborg
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Israel
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Taipei
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Thailand
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Thailand
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Khon Kaen
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Turkey
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Istanbul
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United Kingdom
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Devon
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United Kingdom
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Humberside
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United Kingdom
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Tyne And Wear
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United Kingdom
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Cardiff
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United Kingdom
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London
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Vietnam
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Ha Noi
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Janssen Scientific Affairs, LLC
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

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Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02064439