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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Sponsor:
Bayer
Collaborators:
Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer
Tracking Information | |||||
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First Submitted Date ICMJE | January 24, 2013 | ||||
First Posted Date ICMJE | January 28, 2013 | ||||
Last Update Posted Date | March 27, 2018 | ||||
Actual Study Start Date ICMJE | February 28, 2013 | ||||
Actual Primary Completion Date | July 21, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||
Original Other Outcome Measures ICMJE | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease | ||||
Official Title ICMJE | 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). | ||||
Brief Summary | 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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Condition ICMJE | Prevention &Amp; Control | ||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
27395 | ||||
Original Estimated Enrollment ICMJE |
19500 | ||||
Estimated Study Completion Date | June 30, 2021 | ||||
Actual Primary Completion Date | July 21, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: -- Coronary or peripheral artery disease Patients with coronary artery disease must also meet at least one of the following:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Ecuador, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Ukraine, United Kingdom, United States | ||||
Removed Location Countries | Czech Republic | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01776424 | ||||
Other Study ID Numbers ICMJE | 15786 2012-004180-43 ( EudraCT Number ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | Bayer | ||||
Study Sponsor ICMJE | Bayer | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Bayer | ||||
Verification Date | March 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |