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.

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 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.

• Authors: K Anette Fiedler, Robert A Byrne, Stefanie Schulz, Dirk Sibbing, Julinda Mehilli, Tareq Ibrahim, Michael Maeng, Karl-Ludwig Laugwitz, Adnan Kastrati, Nikolaus Sarafoff
• Journal: American heart journal (Am Heart J) Vol. 167 Issue 4 Pg. 459-465.e1 (Apr 2014) ISSN: 1097-6744 [Electronic] United States
• PMID: 24655693 (Publication Type: Journal Article, Review)
• Copyright: Copyright © 2014 Mosby, Inc. All rights reserved.

Chemical References

• Platelet Aggregation Inhibitors
• Clopidogrel
• Ticlopidine
• Aspirin

Topics

• Administration, Oral
• Aspirin (administration & dosage)
• Clopidogrel
• Coronary Artery Disease (therapy)
• Dose-Response Relationship, Drug
• Drug Therapy, Combination
• Drug-Eluting Stents
• Follow-Up Studies
• Humans
• Percutaneous Coronary Intervention (methods)
• Platelet Aggregation Inhibitors (administration & dosage)
• Randomized Controlled Trials as Topic (methods)
• Thrombolytic Therapy (methods)
• Ticlopidine (administration & dosage, analogs & derivatives)