CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,081 enrolled
Drug / intervention
Rivaroxaban +2 moredrug
Likely dose
Rivaroxaban 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01877915
NCT01877915Phase 3Completed

A Randomized, Double-blind, Event-driven, Multicenter Study Comparing the Efficacy and Safety of Rivaroxaban With Placebo for Reducing the Risk of Death, Myocardial Infarction or Stroke in Subjects With Heart Failure and Significant Coronary Artery Disease Following an Episode of Decompensated Heart Failure

Janssen Research & Development, LLC·interventional·Posted Jun 14, 2013·Updated May 10, 2019

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban, Placebo, and 1 other intervention for Heart Failure and Coronary Artery Disease. Completed, enrolled 5,081 participants across 563 sites in 32 countries.

Detailed 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 participants with heart failure and significant coronary artery disease following an episode of decompensated heart failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsBayer

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 14, 2013
Enrollment StartSep 10, 2013
Primary CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 13.0 years ago

Interventions

Rivaroxabandrug

Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).

Placebodrug

Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).

Standard of care for heart failure and coronary artery diseaseother

Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.