1160.204 RE-CIRCUIT: Dabigatran vs warfarin in AF Ablation
Research type
Research Study
Full title
Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of an uninterrupted periproCedUral antIcoagulation sTrategy (The RE-CIRCUIT Trial).
IRAS ID
170452
Contact name
Timothy Betts
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2014-003890-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 26 days
Research summary
This is a randomised evaluation of dabigatran etexilate compared to warfarin in pulmonary vein ablation to assess the safety and efficacy of using uninterrupted dabigatran etexilate compared with uninterrupted warfarin in patients undergoing pulmonary vein catheter ablation for atrial fibrillation (AF). It is planned to enter 724 patients with non-valvular atrial fibrillation (NVAF) who are already scheduled to undergo catheter ablation for AF. Half the patients will be assigned to receive dabigatran etexilate and half warfarin for 4-8 weeks prior to the procedure (362 planned in each study arm). Treatment will be continued during the procedure and for 60 days afterwards. All patients will be followed up for 9 weeks after the ablation. The length of participation is expected to be between 3 and 4 months for each patient.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0280
Date of REC Opinion
28 May 2015
REC opinion
Favourable Opinion