A study of Rivaroxaban in patients with heart failure when they are hospitalized for worsening of their heart failure

Phase 1

• Conditions: 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; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000046-19-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-25
• Study Completion: 2018-05-02
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 5022

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified