Clinical Trial

Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome

Study acronym: SAPT-ACS
Not Yet Recruiting Phase 4
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Summary
This is a prospective, open-label, multicenter, randomized, phase IV clinical trial designed to evaluate the safety and efficacy of early aspirin discontinuation followed by potent P2Y12 inhibitor monotherapy after intravascular ultrasound (IVUS)-guided drug-eluting stent implantation in patients with acute coronary syndrome. A total of 1,900 patients who achieve complete revascularization after IVUS-guided percutaneous coronary intervention (PCI) and meet the predefined successful IVUS-guided PCI criteria will be randomized in a 1:1 ratio to either the early single antiplatelet therapy group (Early SAPT: ticagrelor or prasugrel monotherapy) or the standard dual antiplatelet therapy group (Standard DAPT: aspirin plus ticagrelor or prasugrel). Randomization will be performed within 96 hours after completion of PCI, and clinical follow-up will be conducted at 1 month, 3 months, 6 months, and 12 months after randomization. The primary endpoints are major adverse cardiovascular events, defined as a composite of all-cause death, myocardial infarction, ischemia-driven target vessel revascularization, and definite or probable stent thrombosis occurring up to 12 months after randomization, and clinically relevant bleeding, defined as Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding occurring up to 12 months after randomization. This study aims to determine whether early P2Y12 inhibitor monotherapy is non-inferior to standard dual antiplatelet therapy (DAPT) for ischemic events and is superior in reducing clinically relevant bleeding.
Trial Details
NCT Number NCT07684742
Lead Sponsor Gyeongsang National University Hospital
Collaborators: Genoss Co., Ltd., CGBio Inc., Biotronik SE & Co. KG, Dio Medical
Conditions Acute Coronary Syndromes, STEMI, NSTEMI, Unstable Angina
Enrollment 1,900 participants
Start Date 2026-07-01
Primary Completion 2031-07-01 (estimated)
Study Completion 2032-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-06