Early single antiplatelet therapy after IVUS-guided PCI in ACS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this multicenter, open-label phase 4 trial, about 2,200 ACS patients who have undergone IVUS-guided PCI achieving complete revascularization are randomized within 96 hours to either early single antiplatelet therapy (P2Y12 inhibitor alone) or standard dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor). Participants are followed for 12 months with assessments at 1, 3, 6, and 12 months to compare major adverse cardiovascular events. The P2Y12 monotherapy option uses prasugrel or ticagrelor, while the DAPT arm combines aspirin with the same P2Y12 choices. The trial aims to determine if early SAPT can maintain safety and efficacy after successful IVUS-guided PCI in ACS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>=19 years
2. Diagnosis of acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)
3. Successful IVUS-guided PCI (with DES for culprit and DES or DCB for non-culprit lesions) achieving complete revascularization and meeting the mandatory procedural criteria
4. Randomization within 96 hours after PCI
5. Written informed consent

Exclusion Criteria:

1. Planned staged PCI or CABG
2. Mandatory procedural criteria not met (e.g., final TIMI flow \<3, significant dissection, thrombus, or malapposition requiring correction)
3. In-stent restenosis lesion
4. Need for oral anticoagulation
5. Major bleeding within 30 days
6. History of hemorrhagic stroke or ischemic stroke within 6 months
7. Platelet count \<100,000/mm3 at screening
8. Contraindication to aspirin, ticagrelor, or prasugrel
9. Life expectancy \<1 year
10. Current or potential pregnancy
11. Investigator deems participation inappropriate

Where it's running

• Gyeongsang National University Hospital
  Jinju, Gyeongsangnam-do, South Korea Recruiting

Study contacts

• Principal investigator: Jin-Sin Koh, MD, PhD — Gyeongsang National University Hospital
• Study coordinator: Jin-Sin Koh, MD, PhD
• Email: kjs0175@gmail.com
• Phone: +82-55-750-8467

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.