title: 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.
  
  
  OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany. Electronic address: anette.fiedler@yahoo.de.
authors.forename: K Anette
authors.initials: KA
authors.lastname: Fiedler
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Byrne
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany.
authors.forename: Stefanie
authors.initials: S
authors.lastname: Schulz
authors.affiliation: Klinikum der Ludwig-Maximilians-Universität, Munich, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Sibbing
authors.affiliation: DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany; Klinikum der Ludwig-Maximilians-Universität, Munich, Germany.
authors.forename: Julinda
authors.initials: J
authors.lastname: Mehilli
authors.affiliation: 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
authors.forename: Tareq
authors.initials: T
authors.lastname: Ibrahim
authors.affiliation: Departement of Cardiology, Aarhus University Hospital, Skeby, Aarhus, Denmark.
authors.forename: Michael
authors.initials: M
authors.lastname: Maeng
authors.affiliation: 1. Medizinische Klinik, Klinikum rechts der Isar, Technische Universität, Munich, Germany.
authors.forename: Karl-Ludwig
authors.initials: KL
authors.lastname: Laugwitz
authors.affiliation: Deutsches Herzzentrum, Technische Universität, Munich, Germany; DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany.
authors.forename: Adnan
authors.initials: A
authors.lastname: Kastrati
authors.affiliation: DZHK (German Centre for Cardiovascular Research), partner site Munich Heart Alliance, Munich, Germany; Klinikum der Ludwig-Maximilians-Universität, Munich, Germany.
authors.forename: Nikolaus
authors.initials: N
authors.lastname: Sarafoff
mesh_terms: D000284:Administration, Oral; D001241:Aspirin / Q000008:administration & dosage*; D000077144:Clopidogrel; D003324:Coronary Artery Disease / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D054855:Drug-Eluting Stents; D005500:Follow-Up Studies; D006801:Humans; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D015912:Thrombolytic Therapy / Q000379:methods*; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin