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 October 2014 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: October 2, 2014
Last verified: October 2014

January 24, 2013
October 2, 2014
March 2013
January 2018   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01776424 on ClinicalTrials.gov Archive Site
  • Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, revascularization, 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 ]
  • 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 ]
Not Provided
Not Provided
 
Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prevention & Control
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
21400
February 2018
January 2018   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937
Hungary,   United States,   Argentina,   Brazil,   Canada,   Chile,   China,   Colombia,   Czech Republic,   Finland,   France,   Germany,   United Kingdom,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Netherlands,   Philippines,   Poland,   South Africa,   Sweden,   Switzerland,   Ukraine
 
NCT01776424
15786, 2012-004180-43
Yes
Bayer
Bayer
Hamilton Health Sciences Corporation, Population Health Research Institute
Study Director: Bayer Study Director Bayer
Bayer
October 2014

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