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

Active, not recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Aspirin Drug
    Intervention Desc: Aspirin 100 mg once daily, tablet
    ARM 1: Kind: Experimental
    Label: Rivaroxaban [2.5mg] + Aspirin
    Description: Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
    ARM 2: Kind: Experimental
    Label: Aspirin + Placebo(2)
    Description: Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
  • Aspirin placebo Drug
    Intervention Desc: Placebo(1), matching Aspirin tablets
    ARM 1: Kind: Experimental
    Label: Rivaroxaban [5mg] + Placebo(1)
    Description: Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
  • Rivaroxaban placebo Drug
    Intervention Desc: Placebo(2), matching Rivaroxaban tablets
    ARM 1: Kind: Experimental
    Label: Aspirin + Placebo(2)
    Description: Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily
  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: Rivaroxaban 5.0 mg twice daily, tablet
    ARM 1: Kind: Experimental
    Label: Rivaroxaban [2.5mg] + Aspirin
    Description: Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
    ARM 2: Kind: Experimental
    Label: Rivaroxaban [5mg] + Placebo(1)
    Description: Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
  • Pantoprazole Drug
    Intervention Desc: Subjects who are not on a PPI (proton pump inhibitor) will also be randomized to pantoprazole or pantoprazole placebo
    ARM 1: Kind: Experimental
    Label: Rivaroxaban [2.5mg] + Aspirin
    Description: Rivaroxaban 2.5 mg twice daily and Aspirin 100 mg once daily
    ARM 2: Kind: Experimental
    Label: Rivaroxaban [5mg] + Placebo(1)
    Description: Rivaroxaban 5 mg twice daily and Aspirin Placebo once daily
    ARM 3: Kind: Experimental
    Label: Aspirin + Placebo(2)
    Description: Rivaroxaban Placebo twice daily and Aspirin 100 mg once daily

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death Approximately 5 years No
Primary Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis) Approximately 5 years Yes
Secondary Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, venous thromboembolism or cardiovascular hospitalization Approximately 5 years No
Secondary Time from randomization to first occurrence of all-cause mortality Approximately 5 years No
Secondary Time from randomization to first occurrence of either myocardial infarction, stroke, cardiovascular death, revascularization, venous thromboembolism or cardiovascular hospitalization Approximately 5 years No
Secondary Time from randomization to first occurrence of either Coronary heart disease death, myocardial infarction, ischemic stroke, acute limb ischemia Approximately 5 years No
Secondary Time from randomization to first occurrence of either Cardiovascular death, myocardial infarction, ischemic stroke, acute limb ischemia Approximately 5 years No

Sponsors