[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646842":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":54,"collaborators":56,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Gyeongsang National University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Single Antiplatelet Therapy Group","EXPERIMENTAL","Patients with acute coronary syndrome who undergo successful IVUS-guided PCI with complete revascularization will be randomized within 96 hours after PCI. After randomization, aspirin will be discontinued immediately, and patients will receive potent P2Y12 inhibitor monotherapy with either prasugrel or ticagrelor.",[13],"Drug: Early P2Y12 Inhibitor Monotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Dual Antiplatelet Therapy Group","ACTIVE_COMPARATOR","Patients with acute coronary syndrome who undergo successful IVUS-guided PCI with complete revascularization will receive standard dual antiplatelet therapy consisting of aspirin plus a potent P2Y12 inhibitor for 12 months.",[19],"Drug: Standard Dual Antiplatelet Therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Early P2Y12 Inhibitor Monotherapy","Participants randomized within 96 hours after successful IVUS-guided PCI will discontinue aspirin immediately after randomization and receive potent P2Y12 inhibitor monotherapy with ticagrelor 90 mg twice daily or prasugrel 10 mg once daily.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Dual Antiplatelet Therapy","Participants randomized within 96 hours after successful IVUS-guided PCI will receive aspirin 100 mg once daily plus a potent P2Y12 inhibitor, consisting of ticagrelor 90 mg twice daily or prasugrel 10 mg once daily, for 12 months.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jin-Sin Koh, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+82-55-750-8467","kjs0175@gmail.com",[41],{"facility":5,"status":26,"city":42,"state":43,"zip":44,"country":45,"countryCode":26,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Jinju","Gyeongsangnam-do","52727","South Korea",{"type":47,"coordinates":48},"Point",[49,50],128.08472,35.19278,{"lat":50,"lon":49},[53],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"type":55,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[57,60,62,64],{"name":58,"class":59},"Genoss Co., Ltd.","INDUSTRY",{"name":61,"class":59},"CGBio Inc.",{"name":63,"class":59},"Biotronik SE & Co. KG",{"name":65,"class":66},"Dio Medical","UNKNOWN","100646842","phase-4-early-single-antiplatelet-therapy-after-ivus-guided-pci-in-acute-coronary-syndrome-100646842",false,"NCT07684742","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","SAPT-ACS","Inclusion Criteria:\n\n1. Age \\>=18 years\n2. Diagnosis of acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or unstable angina (UA)\n3. Successful IVUS-guided PCI with drug-eluting stent implantation\n4. Randomization within 96 hours after PCI\n5. Written informed consent\n\nExclusion Criteria:\n\n1. Planned staged PCI or CABG\n2. PCI failure, including no-reflow, major dissection, or thrombosis\n3. Need for oral anticoagulation\n4. Major bleeding within 30 days\n5. History of hemorrhagic stroke or ischemic stroke within 6 months\n6. Platelet count \\\u003C100,000\u002Fmm3 or WBC count \\\u003C3,000\u002Fmm3\n7. Contraindication to aspirin, ticagrelor, or prasugrel\n8. Life expectancy \\\u003C1 year\n9. Current or potential pregnancy\n10. Investigator deems participation inappropriate","ALL","18 Years",{"count":78,"type":79},1900,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","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.",[85,86,87,88],"Acute Coronary Syndromes","STEMI","NSTEMI","Unstable Angina",[90,91,92,93,94],"Intravascular Ultrasound","Percutaneous Coronary Intervention","Drug-Eluting Stent","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","NOT_YET_RECRUITING","2026-06-29",{"date":98,"type":99},"2026-07-06","ACTUAL",{"date":101,"type":79},"2026-07-01",{"date":103,"type":79},"2032-07-01",{"name":5,"class":6},1]