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
Intervention: Rivaroxaban; Placebo; Standard of care for heart failure and coronary artery disease
Intervention description: 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
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 5081.0
Sex: All
Minimum age: 18 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: Heart Failure; Coronary Artery Disease; Stroke; Myocardial Infarction; Anticoagulation

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have symptomatic heart failure for at least 3 months prior to Screening

          -  Participants must have an episode of decompensated heart failure (index event)
             requiring (a) an overnight stay [that is, staying past midnight] in a hospital,
             emergency department, or medical facility with the capability of treating with
             intravenous medications and observing heart failure patients before randomization or
             (b) an unscheduled outpatient visit to a heart failure management center, where
             parenteral therapy is required for heart failure stabilization. An episode of
             decompensated heart failure is defined as symptoms of worsening dyspnea or fatigue,
             objective signs of congestion such as peripheral edema or ascites, and/or adjustment
             of pre-hospitalization/outpatient visit heart failure medications. Participants are
             eligible for randomization at discharge from the facility treating the index event and
             up to 30 days after discharge if they are in stable condition

          -  Must have a documented left ventricular ejection fraction (LVEF) of less than or equal
             to 40 percent (%) within 1 year before randomization

          -  Must have evidence of significant coronary artery disease

          -  Must be medically stable in terms of their heart failure clinical status at the time
             of randomization

          -  Must have a brain natriuretic peptide (BNP) level greater than or equal to (>=) 200
             picogram per milliliter (pg/mL) or N-terminal-proBNP (NT-proBNP) level >=800 pg/mL
             (preferred assay) during the Screening period and before randomization

        Exclusion Criteria:

          -  Any condition that, in the opinion of the investigator, contraindicates anticoagulant
             therapy or would have an unacceptable risk of bleeding, such as, but not limited to,
             active internal bleeding, clinically significant bleeding, bleeding at a
             noncompressible site, or bleeding diathesis within 28 days of randomization

          -  Severe concomitant disease such as (a) atrial fibrillation (AFib) or another condition
             that requires chronic anticoagulation (participants with isolated transient AFib may
             be allowed at the discretion of the treating physician investigator) and (b)
             Documented acute myocardial infarction (MI) during index event

          -  Prior stroke within 90 days of randomization

          -  Has been hospitalized for longer than 21 days during the index event

          -  Planned intermittent outpatient treatment with positive inotropic drugs administered
             intravenously