A Phase 4 interventional study of BS-DES (Biostable polymer drug-eluting stent) and BD-DES (Biodegradable polymer drug-eluting stent) in Acute Coronary Syndrome, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
Study objectives
Prospective, open-label, 2-by-2 multifactorial, randomized, multicenter trial to test the following in CHD patients
About 3400 patients derived from a population of Korean patients with acute coronary syndrome receiving percutaneous coronary intervention will be enrolled in the present trial.
All patients will receive a loading dose of aspirin (300 mg) and prasugrel (60 mg bolus) will be administered. Sixty-mg-loading dose of prasugrel will be given regardless of pretreated antiplatelet agents (clopidogrel, ticagrelor, or cilostazol). However, in patients who already loaded with other antiplatelet agents (clopidigrel, ticagrelor, or cilostazol), reduced dose (30mg) or omission of prasugrel loading is acceptable. Following angiography, patients with significant diameter stenosis >50% of coronary artery or graft vessel by visual estimation that have documented myocardial ischemia or symptoms of angina, and have lesions that are eligible for coronary intervention without any exclusion criteria, will be randomized 1:1 to either receive either BS-DES or BD-DES group.
At 1-month clinical follow-up, patients eligible for antiplatelet comparison will be additionally randomized 1:1 to either receive the reduce dose of prasugrel (5 mg daily) or conventional dose (10 mg daily). The exclusion criteria (age ≥75 years, body weight \<60 kg, or history of TIA or stroke) is classified as observational cohort. Post-PCI, dual antiplatelet therapy is recommended for at least 1 year. Follow-up data will be collected until 3-year after index procedure.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's enrollment of 3,429 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BS-DES with prasugrel 10mg daily
Device: BS-DES (Biostable polymer drug-eluting stent)
BS-DES with prasugrel 5mg daily
Device: BS-DES (Biostable polymer drug-eluting stent) · Drug: Prasugrel 5mg
BD-DES with prasugrel 10mg daily
Device: BD-DES (Biodegradable polymer drug-eluting stent)
BD-DES with prasugrel 5mg daily
Device: BD-DES (Biodegradable polymer drug-eluting stent) · Drug: Prasugrel 5mg
Also known as: Promus Premier, Xience Alpine, Resolute Onyx
Also known as: Biomatrix, Biomatrix Flex, Nobori, Ultimaster, Synergy, Orsiro
Use prasugrel 5mg daily for maintaning dose
Also known as: Prasugrel
Stent arm : patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or repeat revascularization
Time frame: 12months
Antiplatelet arm : major adverse cardiovascular event (MACE), defined as a composite of all death, MI, stent thrombosis, repeat revascularization, CVA, and BARC class ≥2 bleeding
Time frame: 12months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital