Skip to content

Early Single Antiplatelet Therapy with a Potent P2Y12 Inhibitor After Intravascular Ultrasound–Guided PCI in Patients with Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial

Early Single Antiplatelet Therapy with a Potent P2Y12 Inhibitor After Intravascular Ultrasound–Guided PCI in Patients with Acute Coronary Syndrome: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0012027
Enrollment
1900
Registered
2026-05-22
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The study population will consist of patients diagnosed with acute coronary syndrome (ACS) who undergo percutaneous coronary intervention (PCI), achieve complete revascularization (CR) of all c

Sponsors

Gyeongsang National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Patients diagnosed with acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina 3. Patients who have successfully completed intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) 4. Patients who can be randomized within 96 hours after PCI 5. Patients who provide written informed consent for study participation

Exclusion criteria

Exclusion criteria: 1. Planned staged percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) 2. Failed PCI, including no-reflow, major dissection, thrombus, or other procedural complications 3. Requirement for oral anticoagulant (OAC) therapy 4. History of major bleeding within the previous 30 days 5. History of hemorrhagic stroke or ischemic stroke within the previous 6 months 6. Platelet count <100,000/mm³ or white blood cell count <3,000/mm³ 7. Contraindication to aspirin, prasugrel, or ticagrelor 8. Life expectancy of less than 1 year 9. Current pregnancy, potential pregnancy, or lactation 10. Any condition that, in the investigator’s judgment, makes the patient inappropriate for study participation

Design outcomes

Primary

MeasureTime frame
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.;Clinically relevant bleeding: defined as the incidence of Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding events occurring up to 12 months after randomization.

Secondary

MeasureTime frame
Incidence of major and minor bleeding according to Thrombolysis in Myocardial Infarction (TIMI) criteria;Incidence of major and minor bleeding according to International Society on Thrombosis and Haemostasis (ISTH) criteria;Incidence of all-cause death;Incidence of myocardial infarction;Incidence of ischemia-driven revascularization;Incidence of stent thrombosis;Incidence of net adverse clinical events;All-cause rehospitalization rate;Medication adherence;Survival rate at 12 months

Countries

Korea, Republic of

Contacts

Public ContactHangyul Kim

Gyeongsang National University Hospital

13medicine@naver.com+82-55-750-8000

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jun 29, 2026