6/28/23, 11:38 PM ISAR-TRIPLE Pathway Feedback Search Clinical Topics Home Studies ISAR TRIPLE ISAR TRIPLE Disease Disease Atrial fibrillation Coronary artery disease Trial question What is the optimum duration of triple therapy in patients requiring oral anticoagulation after drug-eluting stent implantation? Study design Multi-center Open label RCT Population Characteristics of study participants 23.0% female N = 614 77.0% male 614 patients (143 female, 471 male) Inclusion criteria: patients who underwent drug-eluting stent implantation and are receiving concomitant aspirin and oral anticoagulation Key exclusion criteria: age 18 years, previous ST, DES implantation in the left main stem, active bleeding or bleeding diathesis, or a history of intracranial bleeding Interventions N=307 clopidogrel treatment for 6 weeks (75 mg daily for 6 weeks; aspirin 75 to 200 mg once daily; and a vitamin K antagonist with either phenprocoumon or warfarin) N=307 clopidogrel treatment for 6 months (75 mg daily for 6 months; aspirin 75 to 200 mg once daily; and a vitamin K antagonist with either phenprocoumon or warfarin) Primary outcome Death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months https://web.pathway.md/studies/rechpWiSJ3mjpqUCC 1/2 6/28/23, 11:38 PM ISAR-TRIPLE Pathway 9.8 % 9.8 8.8 7.4 % 4.9 % 2.5 % No significant difference 0.0 % Clopidogrel treatment for 6 weeks Clopidogrel treatment for 6 months No significant difference in death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months (9.8% vs. 8.8%; HR 1.14, 95% CI 0.68 to 1.91) Secondary outcomes No significant difference in cardiac death, MI, definite stent thrombosis, or ischemic stroke (4% vs. 4.3%; HR 0.93, 95% CI 0.43 to 2.05) No significant difference in TIMI major bleeding (5.3% vs. 4%; HR 1.35, 95% CI 0.64 to 2.84) Conclusion In patients who underwent drug-eluting stent implantation and are receiving concomitant aspirin and oral anticoagulation, clopidogrel treatment for 6 weeks were not superior to clopidogrel treatment for 6 months with respect to death, myocardial infarction, definite stent thrombosis, stroke, or TIMI major bleeding at 9 months. Reference Fiedler KA, Maeng M, Mehilli J et al. Duration of Triple Therapy in Patients Requiring Oral Anticoagulation After Drug-Eluting Stent Implantation: The ISAR-TRIPLE Trial. J Am Coll Cardiol. 2015 Apr 28;65(16):1619-1629. Open reference URL https://web.pathway.md/studies/rechpWiSJ3mjpqUCC 2/2