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

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.

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