A Study to Assess the Effectiveness and Safety of Rivaroxaban in Reducing the Risk of Death, Myocardial Infarction or Stroke in Participants With Heart Failure and Coronary Artery Disease Following an Episode of Decompensated Heart Failure "COMMANDER HF"

Recruiting

Phase 3 Results N/A

Trial Description

The purpose of this study is to assess the effectiveness and safety of rivaroxaban compared with placebo (inactive medication), in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

Detailed Description

This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, in reducing the risk of death, myocardial infarction or stroke in participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a double-blind treatment phase, and a follow-up after the sponsor-announced global treatment end date (GTED, defined as the date when 1200 primary efficacy outcome events are predicted to have occurred). The double-blind treatment phase is estimated to last for 6 to 54 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED and will return to the study center for the end-of-study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The average study duration for participants is expected to be approximately 29 months. The study drug, rivaroxaban, is approved in the United States and in multiple countries around the world for the prevention and treatment of a number of thrombosis-mediated conditions.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
  • Rivaroxaban Drug
    Intervention Desc: Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
    ARM 1: Kind: Experimental
    Label: Rivaroxaban 2.5 mg
    Description: Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
  • Standard of care for heart failure and coronary artery disease Other
    Intervention Desc: Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
    ARM 1: Kind: Experimental
    Label: Rivaroxaban 2.5 mg
    Description: Each participant will receive 2.5 mg of rivaroxaban twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Each participant will receive matching placebo twice daily with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to the first occurrence of any of the following: death from any cause, myocardial infarction, or stroke Day 1 up to approximately Month 30 No
Primary Time to the first occurrence of either fatal bleeding or bleeding into a critical space with potential for permanent disability Day 1 up to approximately Month 30 Yes
Secondary Time to the first occurrence of either death due to a cardiovascular cause or re-hospitalization for worsening of heart failure Day 1 up to approximately Month 30 No
Secondary Time to death due to a cardiovascular cause Day 1 up to approximately Month 30 No
Secondary Time to rehospitalization for worsening of heart failure Day 1 up to approximately Month 30 No
Secondary Time to rehospitalization for cardiovascular events Day 1 up to approximately Month 30 No
Secondary Time to bleeding requiring hospitalization Day 1 up to approximately Month 30 Yes
Secondary Bleeding requiring hospitalization Day 1 up to approximately Month 30 Yes

Sponsors