Phase 3
Completed N=27,395
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
Prevention & Control
Source: ClinicalTrials.gov NCT01776424 ↗
Enrolled (actual)
27,395
Serious AEs
5.7%
Results posted
Oct 2018
Primary outcomePrimary: The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death — 379; 448; 496 Participants — p=0.00004
◆ Published Evidence
Highly cited
2,401citations · ~267 / year
Rivaroxaban with or without Aspirin in Stable Cardiovascular 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.
Linked Publications (5)
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Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease.
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Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial.
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Rivaroxaban with or without aspirin in patients with stable coronary artery disease: an international, randomised, double-blind, placebo-controlled trial.
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Major Adverse Limb Events and Mortality in Patients With Peripheral Artery Disease: The COMPASS Trial.
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Rationale, Design and Baseline Characteristics of Participants in the Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death |
379; 448; 496 | 0.00004 sig |
| PRIMARY The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria |
288; 255; 170 | <0.00001 sig |
| SECONDARY The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death |
329; 397; 450 | 0.00001 sig |
| SECONDARY The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death |
389; 453; 516 | 0.00001 sig |
| SECONDARY All-cause Mortality |
313; 366; 378 | 0.01062 sig |
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
Data sourced from ClinicalTrials.gov (NCT01776424) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.