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

  • 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.

Download full text files

Export metadata

Additional Services

Share in Twitter Search Google Scholar
Metadaten
Author:Christopher P. Cannon, Savion Gropper, Deepak L. BhattORCiDGND, Stephen G. Ellis, Takeshi Kimura, Gregory Y. H. Lip, P. Gabriel Steg, Jurriën Maria ten Berg, Jenny Manassie, Jörg Kreuzer, Jon Blatchford, Joseph M. Massaro, Martina Brückmann, Ernesto Ferreiros Ripoll, Jonas Oldgren, Stefan H. HohnloserORCiD
URN:urn:nbn:de:hebis:30:3-395208
DOI:https://doi.org/10.1002/clc.22572
ISSN:1932-8737
ISSN:0160-9289
Pubmed Id:https://pubmed.ncbi.nlm.nih.gov/27565018
Parent Title (English):Clinical cardiology
Publisher:Wiley
Place of publication:Weinheim [u.a.]
Document Type:Article
Language:English
Year of Completion:2016
Date of first Publication:2016/08/26
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2016/11/01
Tag:Anti platelet therapy; Arrhythmia/all; Cardiac; Clinical trials; General clinical cardiology; Pharmacology; Stroke prevention; Thrombosis/hypercoagulable states; catheterization/diagnostic interventional; management
Volume:39
Issue:10
Page Number:10
First Page:555
Last Page:564
Note:
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.
HeBIS-PPN:427894395
Institutes:Medizin / Medizin
Dewey Decimal Classification:6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung-Nicht kommerziell-Keine Bearbeitung 3.0