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Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)
This study is ongoing, but not recruiting participants.
Sponsor:
Bayer
Collaborators:
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01776424
First received: January 24, 2013
Last updated: April 21, 2017
Last verified: April 2017
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Purpose
The primary purpose of this study is to evaluate whether treatment with rivaroxaban and aspirin or rivaroxaban alone is better than aspirin alone in prevention of heart attacks, stroke or cardiovascular death in patients with coronary or peripheral artery disease.
| Condition | Intervention | Phase |
|---|---|---|
| Prevention &Amp; Control | Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Aspirin placebo Drug: Rivaroxaban placebo Drug: Pantoprazole | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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). |
Resource links provided by NLM:
Further study details as provided by Bayer:
Primary Outcome Measures:
- Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death [ Time Frame: Approximately 5 years ]
- Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ]
Secondary Outcome Measures:
- Time from randomization to first occurrence of either Coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 5 years ]
- Time from randomization to first occurrence of either Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 5 years ]
- Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ]
| Enrollment: | 27395 |
| Actual Study Start Date: | February 28, 2013 |
| Estimated Study Completion Date: | March 31, 2018 |
| Estimated Primary Completion Date: | May 15, 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Rivaroxaban [2.5mg] + Aspirin
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
|
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
|
|
Experimental: Rivaroxaban [5mg] + Placebo(1)
Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776424
Show 570 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776424
Show 570 Study Locations
Sponsors and Collaborators
Bayer
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01776424 History of Changes |
| Other Study ID Numbers: |
15786 2012-004180-43 ( EudraCT Number ) |
| Study First Received: | January 24, 2013 |
| Last Updated: | April 21, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Bayer:
|
Cardiovascular events Rivaroxaban Xarelto anticoagulant blood thinner aspirin ASA CAD coronary disease |
artery disease coronary artery bypass graft stroke heart attack angina arterial vascular disease transient ischemic attack TIA heart disease |
Additional relevant MeSH terms:
|
Peripheral Arterial Disease Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases 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 |
ClinicalTrials.gov processed this record on June 22, 2017