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

This study is currently recruiting participants. (see Contacts and Locations)

Verified September 2016 by Bayer

Sponsor:

Collaborator:

Hamilton Health Sciences Corporation, Population Health Research Institute

Information provided by (Responsible Party):

Bayer

ClinicalTrials.gov Identifier:

NCT01776424

First received: January 24, 2013

Last updated: September 19, 2016

Last verified: September 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

January 24, 2013

Last Updated Date

September 19, 2016

Start Date ^ICMJE

February 2013

Estimated Primary Completion Date

February 2018 (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 ] [ Designated as safety issue: No ]
Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
Time from randomization to first occurrence of either Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Time from randomization to first occurrence of all-cause mortality [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

27400

Estimated Completion Date

March 2018

Estimated Primary Completion Date

February 2018 (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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Bayer Clinical Trials Contact		clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4')	(+)1-888-84 22937

Listed Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, 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

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01776424

Other Study ID Numbers ^ICMJE

15786, 2012-004180-43

Has Data Monitoring Committee

Yes

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

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

September 2016

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

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