Prevention of death, heart attack and stroke in patients with chronic heart failure and significant coronary artery disease following a hospitalization for exacerbation of heart failure. MedDRA version: 16.0 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: Subject must have documented symptomatic chronic HF for at least 3 months prior to screening and must be hospitalized for exacerbation of chronic HF (index hospitalization) before randomization. Subject must have a documented LVEF of less than or equal to 40% within 3 months before randomization. Subject must have evidence of significant CAD. Subject must be medically stable in terms of their heart failure clinical status at the time of randomization. Subject must be receiving appropriate treatment for HF or CAD at the appropriate dosing per guidelines. 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. Subject has a severe concomitant disease or has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments. Subject had a prior stroke within 90 days of randomization. Subject has been hospitalized longer than 21 days during the index hospitalization. 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 a recent hospitalization for exacerbation of heart failure.; 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 a recent hospitalization for exacerbation of heart failure 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): The primary endpoint is the first occurrence of death, MI, or stroke;Timepoint(s) of evaluation of this end point: From randomization to global treatment end date (which is also the end of study visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Composite of CV mortality and re-hospitalization for worsening of HF 2) CV mortality 3) Re-hospitalization for worsening of HF 4) Re-hospitalization for CV events ;Timepoint(s) of evaluation of this end point: From randomization to global treatment end date (which is also the end of study visit) | — |
Countries
Argentina, Bulgaria, China, Czech Republic, Denmark, Estonia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Sweden, Ukraine, United Kingdom, United States
Contacts
Public ContactWilliam Byra, MD
Janssen Research and Development
Outcome results
None listed