Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
| Status: | Active, not recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/28/2019 |
| Start Date: | February 28, 2013 |
| End Date: | June 30, 2021 |
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).
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.
- 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.
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
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
We found this trial at
54
sites
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