COMPASS (BAY 59-7939/15786)
Research type
Research Study
Full 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)
IRAS ID
122902
Contact name
Aideen O Doherty
Contact email
Sponsor organisation
Bayer Healthcare AG
Eudract number
2012-004180-43
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
BAY 59-7939/15786, Bayer Study Number
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
COMPASS is a double blind interventional phase 3 randomised controlled trial that will test rivaroxaban for theprevention of major cardiovascular events in coronary artery disease (CAD) or peripheral artery disease (PAD). The primary purpose is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in the prevention of heart attacks, stroke, or cardiovascular death in patients with coronary or peripheral artery disease.
Eligibility is based on the inclusion and exclusion criteria. The key inclusion criteria are CAD or PAD plus at least one ofthe following: age ≥65 or age ≤65 plus two documented atherosclerosis in at least two vascular beds or at least two additional risk factors.
There are 3 study arms as follows: Rivaroxaban 2.5mg bid +Aspirin 100mg od (experimental), Rivaroxaban 5mg bid +Aspirin placebo od (experimental) and Rivaroxaban placebo bid + Aspirin 100mg od (active comparator). Subjects not on a proton pump inhibitor will also be randomised to pantoprazole or a pantoprazole placebo.The primary completion event is the final follow up visit when at least 2,200 subjects experience an event for the primary efficacy outcome. The primary outcome measures are the time from randomisation to the first occurrence of myocardial infarction, stroke, major bleeding or cardiovascular death which will take approximately 5 years. Secondary outcome measures are time from randomisation to first occurrence of myocardial infarction, stroke, cardiovasculardeath, venous thromboembolism, cardiovascular hospitalisation or all-cause mortality.
The EudraCT number for this trial is 2012-004180-43.
The study sponsor is Bayer Healthcare AG with Hamilton HealthSciences Corporation, Population Health Research Institute as collaborators. A data monitoring committee will be used.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0339
Date of REC Opinion
10 Dec 2013
REC opinion
Further Information Favourable Opinion