Germany-based Boehringer Ingelheim has started new trial, RE-CIRCUIT, to investigate safety and efficacy of uninterrupted anticoagulant treatment with Pradaxa (dabigatran etexilate) in patients with atrial fibrillation (AF) who undergo ablation.
Ablation is a routine, minimally invasive procedure carried out to normalise the heart rhythm.
RE-CIRCUIT is one of a number of new studies currently being initiated by the company within the RE-VOLUTION clinical trial programme, to further research of Pradaxa in different clinical situations and new patient populations.
The RE-VOLUTION clinical trial programme for Pradaxa, which also includes the recently announced RE-DUAL PCI and RE-SPECT ESUS studies, will comprise 15 clinical trials involving more than 55,000 patients in at least 44 countries worldwide when the new trials are completed.
RE-CIRCUIT will include 610 patients with either paroxysmal or permanent AF, who are scheduled to undergo a first ablation procedure.
The company said that results from the RE-CIRCUIT (‘Randomised Evaluation of dabigatran etexilate Compared to warfarIn in pulmonaRy vein ablation: assessment of different peri-proCedUral antIcoagulation sTrategies’) study are expected to be announced in 2016.
Each year, more than 200,000 ablation procedures are conducted worldwide in patients with AF who suffer from an irregular heart rhythm.
According to the company, for most patients with AF, taking an anticoagulant is necessary because their irregular heart beat increases their risk of stroke by up to five times.
Johns Hopkins Hospital professor of cardiology and RE-CIRCUIT study steering committee chairman Hugh Calkins said: "This study will provide valuable insights with regard to the practical management of patients requiring anticoagulation during these procedures.
"We believe that dabigatran may provide a beneficial alternative to standard anticoagulation with warfarin during ablation procedures. The possibility to provide continuous anticoagulation with dabigatran during ablation would simplify management for physicians."
Pradaxa is currently approved in more than 100 countries globally and is the only novel oral anticoagulant with more than six years of long-term data.
Key indication for Pradaxa is the prevention of stroke and systemic embolism in adult patients with non-valvular AF, which current guidelines have issued for Class I recommendations for use of the drug.