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
Condition: Heart Failure; Coronary Artery Disease
MeSH terms: Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Intervention name(s): Rivaroxaban; Placebo; Standard of care for heart failure and coronary artery disease
Intervention type(s): Drug; Drug; Other
Intervention description(s): 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).; 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).; 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.
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Coronary Artery Disease; Stroke; Myocardial Infarction; Anticoagulation