NCT07684742Not yet recruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1900 (estimated)
- First submitted
- 29 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2031
- Lead sponsor
- Gyeongsang National University Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07684742
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1900
- From 1 Jul 2026 to the primary completion date, 1 Jul 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- PCI failure, including no-reflow, major dissection, or thrombosis
- Major bleeding within 30 days
- History of hemorrhagic stroke or ischemic stroke within 6 months
Lab values
- Platelet count \<100,000/mm3 or WBC count \<3,000/mm3
Other
- Planned staged PCI or CABG
- Need for oral anticoagulation
- Contraindication to aspirin, ticagrelor, or prasugrel
- Life expectancy \<1 year
- Current or potential pregnancy
- Investigator deems participation inappropriate
Who the study is looking for
- Age \>=18 years
- Diagnosis of acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)
- Successful IVUS-guided PCI with drug-eluting stent implantation
- Randomization within 96 hours after PCI
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.