COMMANDER-HF: Rivaroxaban in patients with decompensated HF
Research type
Research Study
Full title
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
IRAS ID
178522
Contact name
Chim C. Lang
Contact email
Sponsor organisation
Janssen Cilag International N.V.
Eudract number
2013-000046-19
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
This is a randomized (the study medication is assigned by chance), doubleblind
(neither physician nor participant knows the identity of the assigned treatment), parallel group (each participant group receives different treatments simultaneously), event driven (the study duration is determined by the time taken for a specific number of events to
occur), multicenter study to assess the effectiveness and safety of rivaroxaban compared with placebo, 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. Participants will be randomly assigned in a 1:1 ratio to receive either rivaroxaban or placebo (each in addition to standard of care for heart failure and coronary artery disease as prescribed by their managing physician). The study will consist of a screening phase, a doubleblind treatment phase, and a followup after the sponsor announced global trial end date (GTED, defined as the date when 984 primary efficacy outcome events are predicted to have occurred). The doubleblind treatment phase is estimated to last for 6 to 30 months. Participants will discontinue study drug after taking both their morning and evening doses on the GTED
and will return to the study center for the end of study visit (between 15 and 45 days but no sooner than 15 days after the GTED). Patient safety will be monitored throughout the study. The study duration for each participant is expected to be approximately 16 months. The study drug, rivaroxaban, is approved in the United States and in several countries around the world for the prevention and treatment of a number of thrombosis mediated conditions.
Study assessments include blood and urine testing, vitals signs and weight measurement, assessment of adherence to treatment and adverse events (limited reporting).REC name
West of Scotland REC 1
REC reference
15/WS/0061
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion