TY - JOUR A1 - Cannon, Christopher P. A1 - Gropper, Savion A1 - Bhatt, Deepak L. A1 - Ellis, Stephen G. A1 - Kimura, Takeshi A1 - Lip, Gregory Y. H. A1 - Steg, P. Gabriel A1 - Berg, Jurriën Maria ten A1 - Manassie, Jenny A1 - Kreuzer, Jörg A1 - Blatchford, Jon A1 - Massaro, Joseph M. A1 - Brückmann, Martina A1 - Ferreiros Ripoll, Ernesto A1 - Oldgren, Jonas A1 - Hohnloser, Stefan H. T1 - Design and rationale of the RE-DUAL PCI trial: a prospective, randomized, phase 3b study comparing the safety and efficacy of dual antithrombotic therapy with dabigatran etexilate versus warfarin triple therapy in patients with nonvalvular atrial fibrillation who have undergone percutaneous coronary intervention with stenting T2 - Clinical cardiology N2 - Antithrombotic management of patients with atrial fibrillation (AF) undergoing coronary stenting is complicated by the need for anticoagulant therapy for stroke prevention and dual antiplatelet therapy for prevention of stent thrombosis and coronary events. Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest-sized trial of oral anticoagulation with warfarin and clopidogrel without aspirin showed improvements in both bleeding and thrombotic events compared with triple therapy, but large trials are lacking. The RE-DUAL PCI trial (NCT 02164864) is a phase 3b, a strategy of prospective, randomized, open-label, blinded-endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150 mg twice daily) and a P2Y12 inhibtor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a P2Y12 inhibtor (either clopidogrel or ticagrelor, and low-dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular AF patients who have undergone percutaneous coronary intervention with stenting. The primary endpoint is time to first International Society of Thrombosis and Hemostasis major bleeding event or clinically relevant nonmajor bleeding event. Secondary endpoints are the composite of all cause death or thrombotic events (myocardial infarction, or stroke/systemic embolism) and unplanned revascularization; death or thrombotic events; individual outcome events; death, myocardial infarction, or stroke; and unplanned revascularization. A hierarchical procedure for multiple testing will be used. The plan is to randomize ∼ 2500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population. KW - Anti platelet therapy KW - Arrhythmia/all KW - Cardiac KW - Clinical trials KW - General clinical cardiology KW - Pharmacology KW - Stroke prevention KW - Thrombosis/hypercoagulable states KW - catheterization/diagnostic interventional KW - management Y1 - 2016 UR - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/39520 UR - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-395208 SN - 1932-8737 SN - 0160-9289 N1 - This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. VL - 39 IS - 10 SP - 555 EP - 564 PB - Wiley CY - Weinheim [u.a.] ER -