Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Condition: Prevention & Control
MeSH terms: Peripheral Arterial Disease
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939); Aspirin; Aspirin placebo; Rivaroxaban placebo; Pantoprazole; Pantoprazole placebo
Intervention description: Tablet, 2.5 mg, twice daily, oral; Tablet, 5 mg, twice daily, oral; Tablet, 100 mg, once daily, oral; Aspirin matching placebo, once daily, oral; Rivaroxaban matching placebo, twice daily, oral; Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole; Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo
Intervention MeSH terms: Aspirin; Pantoprazole; Rivaroxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants who consented to COMPASS long-term open-label extension (LTOLE) part received open label rivaroxaban 2.5 mg bid and aspirin 100 mg od in LTOLE part and no blinding procedures were applicable to the LTOLE part.
Enrollment: 27395.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cardiovascular events; Rivaroxaban; Xarelto; Anticoagulant; Blood thinner; Aspirin; ASA; Coronary artery disease; CAD; Peripheral artery disease; PAD; Artery disease; Coronary artery bypass graft; Stroke; Heart attack; Angina; Arterial vascular disease; Myocardial infarction; MI; Cardiovascular Death; CV Death; Heart disease

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.
    

Eligibility criteria:

        Inclusion Criteria:

        - Meet criteria for CAD and/or PAD

        Subjects with CAD must also meet at least one of the following criteria:

          -  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:

          -  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

          -  Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral
             anticoagulant therapy