Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Bayer
Conditions:
Heart Failure
Coronary Artery Disease
Eligibility:
All Genders
18-95 years
Phase:
PHASE3
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 partic...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2018
Estimated Enrollment :
5081 Patients enrolled
Trial Details
Trial ID
NCT01877915
Start Date
September 10 2013
End Date
April 19 2018
Last Update
May 10 2019
Active Locations (563)
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Alexander City, Alabama, United States
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Anchorage, Alaska, United States