ClinicalTrials.gov
ClinicalTrials.gov Menu

Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease (COMPASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01776424
Recruitment Status : Active, not recruiting
First Posted : January 28, 2013
Results First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Collaborators:
Population Health Research Institute
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Prevention & Control Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Aspirin Drug: Aspirin placebo Drug: Rivaroxaban placebo Drug: Pantoprazole Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.)
 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 proton pump inhibitor (PPI) 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 proton pump inhibitor (PPI) 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 proton pump inhibitor (PPI) will also be randomized to pantoprazole or pantoprazole placebo


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The First Occurrence of the Composite Primary Efficacy Outcome, Myocardial Infarction (MI), Stroke, or Cardiovascular (CV) Death [ Time Frame: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of the composite primary efficacy outcome, MI, stroke, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.

  2. The First Occurrence of the Primary Safety Outcome Major Bleeding Based on a Modification of the International Society on Thrombosis and Haemostasis (ISTH) Criteria [ Time Frame: For each participant, the first occurrence of modified ISTH major bleeding after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]

    Modified ISTH major bleeding is defined as: i) Fatal bleeding, or ii) Symptomatic bleeding in a critical area or organ, such as intraarticular, intracranial, intramuscular with compartment syndrome, intraocular, intraspinal, liver, pancreas, pericardial, respiratory, retroperitoneal, adrenal gland or kidney; or bleeding into the surgical site requiring reoperation, or iii) Bleeding leading to hospitalization (major bleeding also includes presentation to an acute care facility with discharge on the same day).

    Count of participants and time from randomization to the first occurrence of the primary safety outcome major bleeding were evaluated. Hazard ratios were calculated and reported as statistical analysis.



Secondary Outcome Measures :
  1. The First Occurrence of Myocardial Infarction (MI), Ischemic Stroke, Acute Limb Ischemia (ALI), or Coronary Heart Disease (CHD) Death [ Time Frame: For each participant, the first occurrence of MI, ALI, or CHD death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CHD death were evaluated. Hazard ratios were calculated and reported as statistical analysis.

  2. The First Occurrence of MI, Ischemic Stroke, ALI, or Cardiovascular (CV) Death [ Time Frame: For each participant, the first occurrence of MI, ischemic stroke, ALI, or CV death after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to the first occurrence of MI, ischemic stroke, ALI, or CV death were evaluated. Hazard ratios were calculated and reported as statistical analysis.

  3. All-cause Mortality [ Time Frame: For each participants, death by any cause after randomization up until the global rivaroxaban/aspirin outcomes cut-off date (06 FEB 2017) was considered. The mean time in follow-up until that date was 702 days. ]
    Count of participants and time from randomization to death by all cause were evaluated. Hazard ratios were calculated and reported as statistical analysis.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


  Show 561 Study Locations
Sponsors and Collaborators
Bayer
Population Health Research Institute
Janssen Research & Development, LLC
Investigators
Study Director: Bayer Study Director Bayer
  Study Documents (Full-Text)

Documents provided by Bayer:
Study Protocol  [PDF] August 19, 2015
Statistical Analysis Plan  [PDF] March 31, 2017

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Publications of Results:

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
Results First Posted: October 5, 2018
Last Update Posted: October 5, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Coronary artery disease
Peripheral artery 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
PAD
Angina
Myocardial infarction
MI
Cardiovascular Death
CV Death

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