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  4. 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 wave undergone percutaneous coronary intervention with stenting
 
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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 wave undergone percutaneous coronary intervention with stenting
File(s)
Cannon_et_al-2016-Clinical_Cardiology.pdf (985.8 KB)
Published version
Author(s)
Cannon, CP
Gropper, S
Bhatt, DL
Ellis, SG
Kimura, T
more
Type
Journal Article
Abstract
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.
Date Issued
2016-08-26
Date Acceptance
2016-06-06
Citation
Clinical Cardiology, 2016, 39 (10), pp.555-564
URI
http://hdl.handle.net/10044/1/40749
DOI
https://www.dx.doi.org/10.1002/clc.22572
ISSN
1932-8737
Publisher
Wiley
Start Page
555
End Page
564
Journal / Book Title
Clinical Cardiology
Volume
39
Issue
10
Copyright Statement
© 2016 The Authors. Clinical Cardiology published by Wiley Periodicals, Inc. 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.
License URL
http://creativecommons.org/licenses/by-nc-nd/4.0/
Subjects
Anti platelet therapy
Arrhythmia/all
Cardiac
Clinical trials
General clinical cardiology
Pharmacology
Stroke prevention
Thrombosis/hypercoagulable states
catheterization/diagnostic interventional
management
RE-DUAL PCI Steering Committee and Investigators
Cardiovascular System & Hematology
1102 Cardiovascular Medicine And Haematology
Publication Status
Published
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