Prevention of death, heart attack and stroke in patients with chronic heart failure and significant coronary artery disease following an episode of decompensated HF (index event). MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849
Conditions
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion 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 prehospitalization/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 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 (NTproBNP) level >=800 pg/ml (preferred assay) during the Screening period and before randomization Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3250
Exclusion criteria
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 noncompressible site, or bleeding diathesis within 28 days of randomization - Severe concomitant disease such as: a) atrial fibrilation (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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that rivaroxaban is superior to placebo in subjects with chronic heart failure and significant coronary artery disease , who are receiving standard care, in reducing the risk of the composite of all-cause mortality, myocardial infarction, or stroke following an index event.; Secondary Objective: The major secondary objectives are to compare rivaroxaban with placebo in addition to standard care in subjects with chronic heart failure and significant coronary artery disease following an index event in reducing the risk of the following outcomes: •Composite of cardiovascular mortality and re-hospitalization for worsening heart failure •Cardiovascular mortality •Re-hospitalization for worsening of heart failure •Re-hospitalization for cardiovascular events ; Primary end point(s): - Time to the first occurence of any of the following: death from any cause, myocardial infarction, or stroke - Time to the first occurence of either fatal bleeding or bleeding into a critical space with potential for permanent disability ; Timepoint(s) of evaluation of this end point: - Day 1 up to approximately Month 54 - Day 1 up to approximately Month 54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to the first occurence of either death due to a cardiovascular cause or re-hospitalization for worsening of heart failure - Time to death due to a cardiovascular cause - Time to rehospitalization for worsening of heart failure - Time to rehospitalization for cardiovascular events - Bleeding requiring hospitalization ; Timepoint(s) of evaluation of this end point: - Day 1 up to approximately Month 54 - Day 1 up to approximately Month 54 - Day 1 up to approximately Month 54 - Day 1 up to approximately Month 54 - Day 1 up to approximately Month 54 | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Latvia, Lithuania, Mexico, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactWilliam Byra, MD
Janssen Research and Development
Outcome results
None listed