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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01776424




Registration number
NCT01776424
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013
Date last updated
16/07/2021

Titles & IDs
Public title
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Scientific title
A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS - Cardiovascular OutcoMes for People Using Anticoagulation StrategieS).
Secondary ID [1] 0 0
2012-004180-43
Secondary ID [2] 0 0
15786
Universal Trial Number (UTN)
Trial acronym
COMPASS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention & Control 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Aspirin
Treatment: Drugs - Aspirin placebo
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Pantoprazole

Experimental: Rivaroxaban [2.5mg] + Aspirin - Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.)

Experimental: Rivaroxaban [5mg] + Placebo(1) - Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily

Active Comparator: Aspirin + Placebo(2) - Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 2.5 mg twice daily, tablet

Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 5.0 mg twice daily, tablet

Treatment: Drugs: Aspirin
Aspirin 100 mg once daily, tablet

Treatment: Drugs: Aspirin placebo
Placebo(1), matching Aspirin tablets

Treatment: Drugs: Rivaroxaban placebo
Placebo(2), matching Rivaroxaban tablets

Treatment: Drugs: Pantoprazole
Subjects who are not on a proton pump inhibitor (PPI) will also be randomized to pantoprazole or pantoprazole placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death - Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Timepoint [1] 0 0
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Primary outcome [2] 0 0
The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria - Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).
Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Timepoint [2] 0 0
For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [1] 0 0
The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death - Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Timepoint [1] 0 0
For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [2] 0 0
The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death - Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Timepoint [2] 0 0
For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.
Secondary outcome [3] 0 0
All-cause Mortality - Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.
Timepoint [3] 0 0
For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days.

Eligibility
Key inclusion criteria
-- Coronary or peripheral artery disease

Patients with coronary artery disease must also meet at least one of the following:

- Age =65, or

- Age <65 and documented atherosclerosis or revascularization involving at least 2
vascular beds, or at least 2 additional risk factors
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral
anticoagulant therapy

- Stroke within 1 month or any history of hemorrhagic or lacunar stroke

- Severe heart failure with known ejection fraction <30% or New York Heart Association
(NYHA) class III or IV symptoms

- Estimated glomerular filtration rate (eGFR)<15 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Bruce
Recruitment hospital [2] 0 0
- Gosford
Recruitment hospital [3] 0 0
- New Lambton Heights
Recruitment hospital [4] 0 0
- Birtinya
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- Brisbane
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- Redcliffe
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- Woolloongabba
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- Adelaide
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- Hobart
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- Launceston
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- Geelong
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- Melbourne
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- Prahran
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- Murdoch
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- Nedlands
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- Taree
Recruitment postcode(s) [1] 0 0
2617 - Bruce
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2250 - Gosford
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2305 - New Lambton Heights
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4575 - Birtinya
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4029 - Brisbane
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4064 - Brisbane
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4020 - Redcliffe
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4102 - Woolloongabba
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5042 - Adelaide
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7000 - Hobart
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7250 - Launceston
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3220 - Geelong
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3052 - Melbourne
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3181 - Melbourne
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3181 - Prahran
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
6009 - Nedlands
Recruitment postcode(s) [18] 0 0
2430 - Taree
Recruitment outside Australia
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United States of America
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Alabama
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Tokyo
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Japan
State/province [189] 0 0
Yamaguchi
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Japan
State/province [190] 0 0
Gifu
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Japan
State/province [191] 0 0
Kumamoto
Country [192] 0 0
Japan
State/province [192] 0 0
Kyoto
Country [193] 0 0
Korea, Republic of
State/province [193] 0 0
Gang''weondo
Country [194] 0 0
Korea, Republic of
State/province [194] 0 0
Gyeonggido
Country [195] 0 0
Korea, Republic of
State/province [195] 0 0
Jejudo
Country [196] 0 0
Korea, Republic of
State/province [196] 0 0
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Korea, Republic of
State/province [197] 0 0
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Korea, Republic of
State/province [198] 0 0
Daejeon
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Korea, Republic of
State/province [199] 0 0
Seoul
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Malaysia
State/province [200] 0 0
Batu Caves, Selangor
Country [201] 0 0
Malaysia
State/province [201] 0 0
Kedah
Country [202] 0 0
Malaysia
State/province [202] 0 0
Kuala Lumpur
Country [203] 0 0
Malaysia
State/province [203] 0 0
Selangor
Country [204] 0 0
Malaysia
State/province [204] 0 0
Sungai Buloh Selangor
Country [205] 0 0
Netherlands
State/province [205] 0 0
Amsterdam
Country [206] 0 0
Netherlands
State/province [206] 0 0
Apeldoorn
Country [207] 0 0
Netherlands
State/province [207] 0 0
Arnhem
Country [208] 0 0
Netherlands
State/province [208] 0 0
Breda
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Netherlands
State/province [209] 0 0
Delft
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Netherlands
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Den Bosch
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Netherlands
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Deventer
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Netherlands
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Doetinchem
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Netherlands
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Drachten
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Netherlands
State/province [214] 0 0
EDE
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Netherlands
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Gorinchem
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Netherlands
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Netherlands
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Netherlands
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Netherlands
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Netherlands
State/province [229] 0 0
Tiel
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Netherlands
State/province [230] 0 0
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Philippines
State/province [232] 0 0
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Philippines
State/province [233] 0 0
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Philippines
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Dasmarinas
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Philippines
State/province [235] 0 0
Iloilo City
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Philippines
State/province [236] 0 0
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Philippines
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Manila
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Philippines
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Philippines
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Philippines
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Philippines
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Pasig city
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Philippines
State/province [242] 0 0
Quezon City
Country [243] 0 0
Philippines
State/province [243] 0 0
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Poland
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State/province [250] 0 0
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Romania
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Brasov
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Romania
State/province [252] 0 0
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Romania
State/province [253] 0 0
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Romania
State/province [254] 0 0
Cluj Napoca
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Romania
State/province [255] 0 0
Iasi
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Romania
State/province [256] 0 0
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Country [257] 0 0
Romania
State/province [257] 0 0
Timisoara
Country [258] 0 0
Russian Federation
State/province [258] 0 0
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Country [259] 0 0
Russian Federation
State/province [259] 0 0
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Russian Federation
State/province [260] 0 0
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Russian Federation
State/province [261] 0 0
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Russian Federation
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Russian Federation
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Slovakia
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Sweden
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Sweden
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Sweden
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Sweden
State/province [278] 0 0
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Sweden
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Sweden
State/province [280] 0 0
Örebro
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Sweden
State/province [281] 0 0
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Country [282] 0 0
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State/province [282] 0 0
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Country [283] 0 0
Ukraine
State/province [283] 0 0
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Country [284] 0 0
Ukraine
State/province [284] 0 0
Kharkiv
Country [285] 0 0
Ukraine
State/province [285] 0 0
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Country [286] 0 0
Ukraine
State/province [286] 0 0
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Country [287] 0 0
Ukraine
State/province [287] 0 0
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Ukraine
State/province [288] 0 0
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Country [289] 0 0
Ukraine
State/province [289] 0 0
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United Kingdom
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Country [291] 0 0
United Kingdom
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Derry
Country [292] 0 0
United Kingdom
State/province [292] 0 0
Essex
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United Kingdom
State/province [293] 0 0
Hertfordshire
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United Kingdom
State/province [294] 0 0
Lancashire
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United Kingdom
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London
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United Kingdom
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United Kingdom
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United Kingdom
State/province [298] 0 0
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United Kingdom
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United Kingdom
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Warwickshire
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United Kingdom
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West Midlands
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Worcestershire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Janssen Research & Development, LLC
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objectives of this study are:

- To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily
(od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial
infarction, stroke, or cardiovascular death in subjects with coronary artery disease
(CAD) or peripheral artery disease (PAD);

- To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the
risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects
with CAD or PAD.
Trial website
https://clinicaltrials.gov/show/NCT01776424
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
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications