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

This study is ongoing, but not recruiting participants.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2013

Last Updated Date

April 21, 2017

Actual Start Date ^ICMJE

February 28, 2013

Estimated Primary Completion Date

May 15, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, venous thromboembolism or cardiovascular hospitalization [ Time Frame: Approximately 5 years ]
Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ]

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: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Prevention

Condition ^ICMJE

Prevention &Amp; Control

Intervention ^ICMJE

Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 2.5 mg twice daily, tablet
Drug: Rivaroxaban (Xarelto, BAY59-7939)
Rivaroxaban 5.0 mg twice daily, tablet
Drug: Aspirin
Aspirin 100 mg once daily, tablet
Drug: Aspirin placebo
Placebo(1), matching Aspirin tablets
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

Study Arms

Experimental: Rivaroxaban [2.5mg] + Aspirin
Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
Interventions:
- Drug: Rivaroxaban (Xarelto, BAY59-7939)
- Drug: Aspirin
- Drug: Pantoprazole
Experimental: Rivaroxaban [5mg] + Placebo(1)
Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
Interventions:
- Drug: Rivaroxaban (Xarelto, BAY59-7939)
- Drug: Aspirin placebo
- Drug: Pantoprazole
Active Comparator: Aspirin + Placebo(2)
Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
Interventions:
- Drug: Aspirin
- Drug: Rivaroxaban placebo
- Drug: Pantoprazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

27395

Estimated Completion Date

March 31, 2018

Estimated Primary Completion Date

May 15, 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:

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

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 )

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Bayer

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Hamilton Health Sciences Corporation, Population Health Research Institute
Janssen Research & Development, LLC

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

PRS Account

Bayer

Verification Date

April 2017

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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