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)
- Conditions
- coronary and peripheral artery diseaseatherosclerosis1001108210003216
- Registration Number
- NL-OMON47095
- Lead Sponsor
- Bayer B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1350
CAD or PAD (see protocol for definitions) plus at least one of the following:
o Age *65
o Age <65 plus documented atherosclerosis in two vascular beds or at least 2
additional risk factors (see protocol for details) ;All subjects randomized to the COMPASS trial willing to consent to LTOLE are
eligible unless the subjects developed a condition considered by the investigator as
exclusionary.
* Subjects who have given their written informed consent to participate in the LTOLE
after having received adequate information prior to any LTOLE specific procedures.
- High risk of bleeding
- Stroke within 1 month or any history of hemorrhagic or lacunar stroke
- Ejection fraction <30% or NYHA class III or IV symptoms
- eGFR<15 mL/min
- Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy or oral anticoagulant therapy
- Systemic treatment with strong CYP 3A4 and P-gp inhibitors
- Inadequate contraception for females of childbearing potential
- Pregnancy, breast feeding;Subjects should not be included in the LTOLE study if, in the judgement of the investigator, they have
developed a condition which should exclude them from receiving LTOLE study
medication. For example if the subject has developed atrial fibrillation or had a severe
allergic rash while in the study, which subsided when drug was stopped and returned
when drug was reinitiated.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy: Composite of myocardial infarction, stroke, or cardiovascular death.<br /><br>Safety: modified International Society on Thrombosis and Haemostasis major<br /><br>bleeding.<br /><br><br /><br>LTOLE: the same primary safety and efficacy variables will be collected.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Composite of myocardial infarction, stroke, cardiovascular death,<br /><br>revasculatization and venous thromboembolism and cardiovascular hospitalization.<br /><br>Mortality.<br /><br>Upper gastrointestinal bleeding, ulceration, and gastrointestinal obstruction<br /><br>or perforation.</p><br>