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

Condition(s) studied

Investigational drug(s) / intervention(s)

Early P2Y12 Inhibitor Monotherapy: Participants randomized within 96 hours after successful IVUS-guided PCI will discontinue aspirin immediately after randomization and receive potent P2Y12 inhibitor monotherapy with ticagrelor 90 mg twice daily or prasugrel 10 mg once daily.

Standard Dual Antiplatelet Therapy: Participants randomized within 96 hours after successful IVUS-guided PCI will receive aspirin 100 mg once daily plus a potent P2Y12 inhibitor, consisting of ticagrelor 90 mg twice daily or prasugrel 10 mg once daily, for 12 months.

Study 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.

Eligibility

Primary outcome measure(s)

• Major Adverse Cardiovascular Events — Up to 12 months after randomization
  Major adverse cardiovascular events are 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.
• Clinically Relevant Bleeding — Up to 12 months after randomization
  Clinically relevant bleeding is defined as the incidence of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events occurring up to 12 months after randomization.

Trial sites (1)

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