ENSURE in AF (atrial fibrillation) study
Research type
Research Study
Full title
A prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU-176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation
IRAS ID
149126
Contact name
Gregory Lip
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2013-003148-21
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Atrial fibrillation (AF) is an abnormal heart rhythm that results in irregular heartbeats. Atrial fibrillation is the most common type of change in the rhythm of the heartbeat in adults. Atrial fibrillation is a condition that becomes more common as people get older. Electrical cardioversion is a procedure that is used to help return the heartbeat to its normal rhythm.
Patients with atrial fibrillation have a higher risk of having a stroke and other blood clot complications. A stroke happens when a blood vessel in the brain begins to leak or gets a clot in it. At the present time, patients with atrial fibrillation undergoing a cardioversion procedure are most commonly treated with a medicine called warfarin and sometimes other blood-thinning drugs, including enoxaparin or aspirin.
The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in patients with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion.
This study aims to recruit 2,200 patients. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for a maximum of 82 days. Study procedures will include physical examinations, vital signs (pulse and sitting blood pressure), ECG (electrocardiogram), finger prick blood clotting tests, blood samples, urine samples and completion of Quality of Life questionnaires.
The study is sponsored by Daiichi Sankyo, with approximately 25 hospital sites in the UK taking part.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
14/EE/0102
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion