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Triple antithrombotic therapy, typically comprising warfarin, aspirin, and clopidogrel, is associated with a high risk of bleeding. A modest\u2010sized 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 <jats:styled-content style=\"fixed-case\">RE\u2010DUAL PCI<\/jats:styled-content> trial (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content> 02164864) is a phase 3b, a strategy of prospective, randomized, open\u2010label, blinded\u2010endpoint trial. The main objective is to evaluate dual antithrombotic therapy with dabigatran etexilate (110 or 150\u2009mg twice daily) and a  P2Y12 inhibitor (either clopidogrel or ticagrelor) compared with triple antithrombotic therapy with warfarin, a  P2Y12 inhibitor (either clopidogrel or ticagrelor, and low\u2010dose aspirin (for 1 or 3 months, depending on stent type) in nonvalvular <jats:styled-content style=\"fixed-case\">AF<\/jats:styled-content> 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\u2009\u223c\u20092500 patients at approximately 550 centers worldwide to try to identify new treatment strategies for this patient population.<\/jats:p>","DOI":"10.1002\/clc.22572","type":"journal-article","created":{"date-parts":[[2016,8,26]],"date-time":"2016-08-26T15:56:54Z","timestamp":1472227014000},"page":"555-564","source":"Crossref","is-referenced-by-count":65,"title":["Design and Rationale of the <scp>RE\u2010DUAL PCI<\/scp> 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"],"prefix":"10.1002","volume":"39","author":[{"given":"Christopher P.","family":"Cannon","sequence":"first","affiliation":[{"name":"Harvard Clinical Research Institute Boston, Massachusetts"},{"name":"Cardiovascular Division Brigham and Women's Hospital  Boston, Massachusetts"},{"name":"Harvard Medical School  Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Savion","family":"Gropper","sequence":"additional","affiliation":[{"name":"Boehringer Ingelheim Pharma GmbH &amp; Co. 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