Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* Male and female patients aged 40 years or more
* Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:

  * Heart failure, New York Heart Association (NYHA) class III or IV
  * Active cancer
  * Acute ischemic stroke
  * Acute infectious and inflammatory diseases, including acute rheumatic diseases
  * Acute respiratory insufficiency
  * Additional risk factor for VTE, including reduced mobility

Exclusion Criteria:

* Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
* Conditions that may increase the risk of bleeding, including intracranial hemorrhage
* Required drugs or procedures which may interfere with the study treatment
* Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
* General conditions in which subjects are not suitable to participate in the study
C: Inclusion Criteria:

Inclusion Criteria:

* Patients with NYHA class II, III, or IV and left ventricular ejection fractions less than or equal to 35%, on an ACE inhibitor (unless not tolerated) and on a diuretic.

Exclusion Criteria:
D: Inclusion Criteria

* Cardiac EF \<=35% by radionuclide ventriculography, left ventriculography or quantitive echocardiographic measurement or an echocardiographic Wall Motion Index of \<=1.2, within three months of enrollment. The patient's clinical cardiac state at enrollment should be similar to their state at the time of the qualifying echocardiogram. The qualifying left ventricular function measurement must be obtained at least three months after an MI, coronary bypass grafting, PTCA, and at least one month after pacemaker insertion. Patients scheduled for mitral valve repair should have qualifying echo after surgery.
* Modified Rankin score \<=4.
* Patient must be taking ACE inhibitors. If intolerant of ACE inhibitor, patient must be on angiotensin II receptor blockers or hydralazine and nitrates.
* Patient is able to follow an outpatient protocol (requiring monthly blood tests and clinic visits every four months for the duration of the study) and is available by telephone.
* Patient understands the purpose and requirements of the study, can make him/herself understood, and has provided informed consent.
* Patients with recent stroke or TIA within twelve (12) months will be eligible to be included in the recent stroke (RS) subgroup.
* Chronic CHF patients (NYHA I \* IV) admitted to the hospital can be randomized prior to discharge if the patient is stable, taking oral medications for 24 hours and ambulatory at the time of discharge. Stable New York Heart Association Class IV patients will be eligible for randomization.

Exclusion Criteria

* The presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal AF, mechanical valve, endocarditis, intracardiac mobile or pedunculated thrombus, and valvular vegetation.
* Cyanotic congenital heart disease, Eisenmenger's syndrome.
* Decompensated heart failure.
* Cardiac surgery, angioplasty, or MI within the past 3 months prior to randomization.
* A contraindication to the use of either warfarin or aspirin, e.g. active peptic ulcer disease, active bleeding diathesis, platelets \<100,000\*, hematocrit \<30, INR \>1.3 (if not on warfarin), clotting factor abnormality that increases the risk of bleeding, alcohol or substance abuse, severe gait instability, cerebral hemorrhage, systemic hemorrhage within the past year, severe liver impairment (AST \>3x normal\*, cirrhosis), any condition requiring regular use of non-steroidal anti-inflammatory agents, allergy to aspirin or warfarin, uncontrolled severe hypertension (systolic pressure \>180 mm Hg or diastolic pressure \> 110 mm Hg), positive stool guaiac not attributable to hemorrhoids, creatinine \>3.0\*. \*on most recent test done within 30 days prior to randomization
* Patient needs continuing therapy with intravenous heparin or low molecular weight heparin or a specific antiplatelet agent.
* Dementia or psychiatric or physical problem that prevents the patient from following an outpatient program reliably.
* Comorbid conditions that may limit survival to less than five years.
* Pregnancy, or female of childbearing potential who is not sterilized or is not using a medically accepted form of contraception\* (see procedure manual). \*A pregnancy test is required for all women of childbearing age.
* Enrollment in another study that would conflict with WARCEF.
* Hospitalization for new diagnosis of onset CHF within the past one month or carotid endarterectomy or pacemaker insertion within the past one month prior to randomization .
* Person under 18 years of age.

Answer: A