Edoxaban vs. VKA in Subjects undergoing Catheter Ablation:ELIMINATE-AF
Research type
Research Study
Full title
A Prospective, Randomized, Open-Label, Blinded Endpoint Evaluation (PROBE) Parallel Group Study Comparing Edoxaban vs. VKA in Subjects Undergoing Catheter Ablation of Non-valvular Atrial Fibrillation (ELIMINATE-AF).
IRAS ID
213874
Contact name
Heiko Rauer
Contact email
Sponsor organisation
Daiichi Sankyo Europe GmbH
Eudract number
2016-003069-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 8 months, 1 days
Research summary
Atrial Fibrillation (AF) is one of the most common forms of abnormal heart rhythm in adults and a major cause of stroke. Catheter ablation (CA) is a treatment that aims to control or correct certain types of abnormally fast heart rhythms, however, it is associated with a significant thrombo-embolic risk and the use of oral anticoagulants during the procedure, is warranted. Anticoagulants are “blood-thinning” drugs that help prevent blood clots and reduce the risk of strokes, however, they also increase the risks of bleeding and require regular visits to the hospital or GP surgery for blood tests.
In this study, a new type of anticoagulant drug called edoxaban, will be compared to warfarin to look at how safe and effective these drugs are in reducing the risk of thromboembolic complications.
The study aims to identify the optimal oral anticoagulant treatment prior to and after the ablation procedure, in patients with AF who are scheduled for catheter ablation. Patients included in the trial will be randomly assigned to receive either edoxaban or warfarin and will take one of these drugs before being assessed for suitability for the ablation procedure.
Patients enroled in the study will undergo study procedures including physical examinations, blood draws, vital signs measurements, ECGs (Electrocardiograms) and transesophageal echocardiogram (TEE). It is planned that approximately 560 patients will enter this study, which is being conducted at hospital sites throughout Europe, Canada, Korea and Taiwan. Approximately 4 hospital sites in the UK will take part. Male and female patients aged 18 years and above may be eligible to take part and will be in the study for 5 to 6 months.
This study is sponsored by Daiichi Sankyo Europe GmbH.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
17/SC/0025
Date of REC Opinion
24 Feb 2017
REC opinion
Further Information Favourable Opinion