Rationale and design of the Intracoronary Stenting and Antithrombotic Regimen - Testing of a six-week versus a six-month clopidogrel treatment Regimen in Patients with concomitant aspirin and oraL anticoagulant therapy following drug-Eluting stenting (ISAR-TRIPLE) study
Fiedler KA, Byrne RA, Schulz S, Sibbing D, Mehilli J, Ibrahim T, Maeng M, Laugwitz KL, Kastrati A, Sarafoff N (2014)
Publication Type: Journal article
Publication year: 2014
Journal
Book Volume: 167
Pages Range: 459-465.e1
Journal Issue: 4
DOI: 10.1016/j.ahj.2014.01.005
Abstract
Background An increasing number of patients undergoing coronary stenting need lifelong anticoagulation and therefore require a triple therapy typically consisting of aspirin, clopidogrel, and a vitamin K antagonist. Triple therapy confers an elevated bleeding risk as compared with dual therapy; however, omission of either antiplatelet or anticoagulation therapy might increase the risk of stent thrombosis or thrombembolic events. Although guidelines recommend a duration of dual antiplatelet therapy of 6 to 12 months after drug-eluting stent (DES) implantation, the optimal duration of dual antiplatelet therapy in patients receiving oral anticoagulation is not known. Hypothesis We postulate that 6-week clopidogrel therapy after DES implantation as compared with 6-month therapy is associated with improved clinical outcomes in patients undergoing DES implantation receiving concomitant aspirin and vitamin K antagonists. Study design The ISAR-TRIPLE is a randomized, open-label trial that examines the restriction of clopidogrel therapy from 6 months to 6 weeks after DES implantation in the setting of concomitant aspirin and oral anticoagulant. Patients are randomized in a 1:1 fashion to either 6-week or 6-month clopidogrel therapy. The primary end point is a composite of death, myocardial infarction, definite stent thrombosis, stroke, or major bleeding. The secondary end point comprises ischemic and bleeding complications. According to sample size calculations, a total of 600 patients are required to be enrolled. Clinical follow-up is scheduled at 6 weeks and at 6 and 9 months after randomization. Summary There is clinical equipoise regarding the optimal duration of triple therapy after DES implantation in patients who need vitamin K antagonist therapy. The ISAR-TRIPLE trial aims to test the hypothesis that a 6-week triple therapy compared with a 6-month triple therapy improves net clinical outcomes. © 2014 Mosby, Inc.
Involved external institutions
Technische Universität München (TUM)
Germany (DE)
Klinikum der Universität München (Großhadern und Innenstadt)
Germany (DE)
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK e.V.)
Germany (DE)
Aarhus University Hospital / Aarhus Universitetshospital
Denmark (DK)
Germany (DE)
Klinikum der Universität München (Großhadern und Innenstadt)
Germany (DE)
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK e.V.)
Germany (DE)
Aarhus University Hospital / Aarhus Universitetshospital
Denmark (DK)
How to cite
APA:
Fiedler, K.A., Byrne, R.A., Schulz, S., Sibbing, D., Mehilli, J., Ibrahim, T.,... Sarafoff, N. (2014). Rationale and design of the Intracoronary Stenting and Antithrombotic Regimen - Testing of a six-week versus a six-month clopidogrel treatment Regimen in Patients with concomitant aspirin and oraL anticoagulant therapy following drug-Eluting stenting (ISAR-TRIPLE) study. American Heart Journal, 167(4), 459-465.e1. https://doi.org/10.1016/j.ahj.2014.01.005
MLA:
Fiedler, K. Anette, et al. "Rationale and design of the Intracoronary Stenting and Antithrombotic Regimen - Testing of a six-week versus a six-month clopidogrel treatment Regimen in Patients with concomitant aspirin and oraL anticoagulant therapy following drug-Eluting stenting (ISAR-TRIPLE) study." American Heart Journal 167.4 (2014): 459-465.e1.
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