NCT07684742 Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
| NCT ID | NCT07684742 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Gyeongsang National University Hospital |
| Condition | Acute Coronary Syndromes |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,200 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2031-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 2,200 participants in total. It began in 2026-07-01 with a primary completion date of 2031-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 2,200 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 Criteria
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
Contact & Investigator
Jin-Sin Koh, MD, PhD
PRINCIPAL INVESTIGATOR
Gyeongsang National University Hospital
Frequently Asked Questions
Who can join the NCT07684742 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Acute Coronary Syndromes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07684742 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07684742 currently recruiting?
Yes, NCT07684742 is actively recruiting participants. Contact the research team at kjs0175@gmail.com for enrollment information.
Where is the NCT07684742 trial being conducted?
This trial is being conducted at Jinju, South Korea.
Who is sponsoring the NCT07684742 clinical trial?
NCT07684742 is sponsored by Gyeongsang National University Hospital. The principal investigator is Jin-Sin Koh, MD, PhD at Gyeongsang National University Hospital. The trial plans to enroll 2,200 participants.