Randomized Evaluation of Dabigatran Etexilate Compared to warfarIn in pulmonaRy Vein Ablation: Assessment of an Uninterrupted periproCedUral alntIcoagulation sTrategy
Phase of Trial: Phase IV
Latest Information Update: 18 Sep 2017
At a glance
- Drugs Dabigatran etexilate (Primary) ; Warfarin
- Indications Stroke; Thrombosis
- Focus Adverse reactions
- Acronyms RE-CIRCUIT
- Sponsors Boehringer Ingelheim
- 18 Sep 2017 According to a Boehringer Ingelheim media release, the CHMP of the EMA has issued a positive opinion for an update to the European Summary of Product Characteristics (SmPC) of Pradaxa for the treatment of patients with atrial fibrillation. The CHMP recommends to include data from this trial.If approved, the updated SmPC will state that AF patients undergoing catheter ablation who take Pradaxa 150 mg twice daily will not need to stop taking their Pradaxa medication.
- 19 Mar 2017 Primary endpoint of incidence of Major Bleeding Events has been met, according to results published in the New England Journal of Medicine.
- 19 Mar 2017 Results published in the New England Journal of Medicine