Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)
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ClinicalTrials.gov Identifier: NCT01776424 |
Recruitment Status
:
Active, not recruiting
First Posted
: January 28, 2013
Last Update Posted
: March 27, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention &Amp; Control | Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Aspirin placebo Drug: Rivaroxaban placebo Drug: Pantoprazole | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27395 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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). |
Actual Study Start Date : | February 28, 2013 |
Actual Primary Completion Date : | July 21, 2017 |
Estimated Study Completion Date : | June 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Rivaroxaban [2.5mg] + Aspirin
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily. (Long-term open-label extension was added to make rivaroxaban 2.5 mg twice daily + aspirin 100 mg once daily available to COMPASS trial subjects until the rivaroxaban treatment is commercially available for this indication or for approximately 3 years from regulatory approval of the long term open label extension in a country, whichever comes first.)
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Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 2.5 mg twice daily, tablet
Drug: Aspirin
Aspirin 100 mg once daily, tablet
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
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Experimental: Rivaroxaban [5mg] + Placebo(1)
Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
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Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 5.0 mg twice daily, tablet
Drug: Aspirin placebo
Placebo(1), matching Aspirin tablets
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
|
Active Comparator: Aspirin + Placebo(2)
Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
|
Drug: Aspirin
Aspirin 100 mg once daily, tablet
Drug: Rivaroxaban placebo
Placebo(2), matching Rivaroxaban tablets
Drug: Pantoprazole
Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
|
- Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 6 years ]
- Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 6 years ]
- Time from randomization to first occurrence of either coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]
- Time from randomization to first occurrence of either cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 6 years ]
- Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 6 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776424

Study Director: | Bayer Study Director | Bayer |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Bayer |
ClinicalTrials.gov Identifier: | NCT01776424 History of Changes |
Other Study ID Numbers: |
15786 2012-004180-43 ( EudraCT Number ) |
First Posted: | January 28, 2013 Key Record Dates |
Last Update Posted: | March 27, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Bayer:
coronary disease artery disease coronary artery bypass graft stroke heart attack arterial vascular disease heart disease Cardiovascular events Rivaroxaban |
Xarelto anticoagulant blood thinner aspirin ASA CAD angina transient ischemic attack TIA |
Additional relevant MeSH terms:
Peripheral Arterial Disease Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases Atherosclerosis Arteriosclerosis Aspirin Rivaroxaban Pantoprazole Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Anticoagulants |