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
- Conditions
- Prevention of death, heart attack and stroke in patients with heart failure and significant coronary artery disease following an episode of de compensated HF (index event).MedDRA version: 19.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2013-000046-19-DK
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5022
- 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 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method