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
| Autor: | Stefanie Schulz, Karl-Ludwig Laugwitz, Adnan Kastrati, Nikolaus Sarafoff, Michael Maeng, Tareq Ibrahim, Robert A. Byrne, K. Anette Fiedler, Julinda Mehilli, Dirk Sibbing |
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| Rok vydání: | 2013 |
| Předmět: |
medicine.medical_specialty
Ticlopidine medicine.drug_class medicine.medical_treatment Administration Oral Coronary Artery Disease Pharmacotherapy Percutaneous Coronary Intervention medicine Humans Thrombolytic Therapy cardiovascular diseases Stroke Randomized Controlled Trials as Topic Aspirin Dose-Response Relationship Drug business.industry Stent Drug-Eluting Stents Vitamin K antagonist medicine.disease Clopidogrel Surgery Anesthesia Platelet aggregation inhibitor Drug Therapy Combination Cardiology and Cardiovascular Medicine business Platelet Aggregation Inhibitors medicine.drug Follow-Up Studies |
| Zdroj: | Fiedler, K A, Byrne, R A, Schulz, S, Sibbing, D, Mehilli, J, Ibrahim, T, Maeng, M, Laugwitz, K-L, Kastrati, A & 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, vol. 167, no. 4, pp. 459-465.e1 . https://doi.org/10.1016/j.ahj.2014.01.005 |
| ISSN: | 1097-6744 |
| DOI: | 10.1016/j.ahj.2014.01.005 |
| Popis: | 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 12months 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. |
| Databáze: | OpenAIRE |
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