Boehringer Ingelheim has announced a new study of Pradaxa (dabigatran etexilate) in patients with atrial fibrillation (AF). The RE-CIRCUIT study will investigate the safety and efficacy of uninterrupted anticoagulant treatment with Pradaxa in patients with AF who undergo ablation. Results of the study are expected in 2016.
“Currently there are no international guidelines regarding the specific use of novel oral anticoagulants (NOACs) during ablation procedures, despite their wide use in patients with atrial fibrillation. This study will provide valuable insights with regard to the practical management of patients requiring anticoagulation during these procedures,” comments Hugh Calkins, chairman of the RE-CIRCUIT study Steering Committee and professor of cardiology and director of the Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Hospital, Baltimore, USA. “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.”
RE-CIRCUIT is one of a number of new studies currently being initiated by Boehringer Ingelheim within the RE-VOLUTION clinical trial programme, to further research of Pradaxa in different clinical situations and new patient populations. The extensive RE-VOLUTION clinical trial programme for Pradaxa, which also encompasses the recently announced RE-DUAL PCI and RE-SPECT ESUS studies, will include 15 clinical trials involving over 55,000 patients in more than 44 countries globally when the new trials are completed.
Pradaxa is currently approved in over 100 countries worldwide and is the only novel oral anticoagulant with more than six years of long-term data. The key indication for Pradaxa is the prevention of stroke and systemic embolism in adult patients with non-valvular AF, for which current guidelines have issued Class I recommendations for use of Pradaxa. Clinical experience of Pradaxa equates to over three million patient-years in all licensed indications.