[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573180":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":35,"locations":44,"responsibleParty":308,"collaborators":311,"id":314,"slug":315,"hasResults":316,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":316,"sex":322,"minAge":323,"maxAge":23,"enrollmentInfo":324,"targetDuration":23,"studyType":327,"phases":328,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":47,"whyStopped":23,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":348},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Discontinuation of antiplatelet agent group","EXPERIMENTAL","In this group, antiplatelet monotherapy will be discontinued at the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, all antiplatelet agents will be discontinued after randomization.",[13],"Other: Discontinuation of antiplatelet agent group",{"label":15,"type":16,"description":17,"interventionNames":18},"Continuation of antiplatelet agent group","ACTIVE_COMPARATOR","In this group, lifelong antiplatelet monotherapy will be continued after the time of randomization. Randomization will be performed at 1 year from the index procedure using DCB angioplasty, standard duration of DAPT (1-3 months), and maintenance of antiplatelet monotherapy at least 1 year from the index procedure in patients with HBR and chronic coronary syndrome. In patients who are still under DAPT at 1 year from index DCB angioplasty, DAPT will be changed to single antiplatelet therapy (aspirin or clopidogrel). The choice between aspirin or clopidogrel will be determined by the physician's discretion.",[19],"Other: Continuation of antiplatelet agent group",[21,24],{"type":6,"name":9,"description":11,"armGroupLabels":22,"otherNames":23},[9],null,{"type":6,"name":15,"description":17,"armGroupLabels":25,"otherNames":23},[15],[27,30,32],{"name":28,"affiliation":5,"role":29},"Joo-Yong Hahn, MD, PhD","STUDY_CHAIR",{"name":31,"affiliation":5,"role":29},"Young Bin Song, MD, PhD",{"name":33,"affiliation":5,"role":34},"Joo Myung Lee, MD, MPH, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":23,"email":39},"CONTACT","82-2-3410-2575","drone80@hanmail.net",{"name":41,"role":37,"phone":42,"phoneExt":23,"email":43},"Seung Hun Lee, MD, PhD","82-10-6413-7449","lsh8602@naver.com",[45,61,74,87,107,124,141,154,164,176,191,210,223,239,249,268,278,291],{"facility":46,"status":47,"city":48,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Korea University Ansan Hospital","RECRUITING","Ansan","South Korea",{"type":51,"coordinates":52},"Point",[53,54],126.52613,35.46836,{"lat":54,"lon":53},[57,60],{"name":58,"role":37,"phone":23,"phoneExt":23,"email":59},"Sunwon Kim, MD, PhD","sunwon11@hanmail.net",{"name":58,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":62,"status":47,"city":63,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Keimyung University Dongsan Medical Center","Daegu",{"type":51,"coordinates":65},[66,67],128.59111,35.87028,{"lat":67,"lon":66},[70,73],{"name":71,"role":37,"phone":23,"phoneExt":23,"email":72},"Hyuck-Jun Yoon, MD, PhD","hippsons@gmail.com",{"name":71,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":75,"status":47,"city":76,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Gangneung Asan Hospital, University of Ulsan College of Medicine","Gangneung",{"type":51,"coordinates":78},[79,80],128.87239,37.75266,{"lat":80,"lon":79},[83,86],{"name":84,"role":37,"phone":23,"phoneExt":23,"email":85},"Hanbit Park, MD, PhD","phb8012@gmail.com",{"name":84,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":88,"status":47,"city":89,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Ilsan Paik hospital","Goyang",{"type":51,"coordinates":91},[92,93],127.19731,36.21689,{"lat":93,"lon":92},[96,99,100,103,105],{"name":97,"role":37,"phone":23,"phoneExt":23,"email":98},"Joon-Hyung Doh, MD,PhD","joon.doh@gmail.com",{"name":97,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":101,"role":102,"phone":23,"phoneExt":23,"email":23},"Sung Woo Cho, MD,PhD","SUB_INVESTIGATOR",{"name":104,"role":102,"phone":23,"phoneExt":23,"email":23},"Sung-Eun Kim, MD,PhD",{"name":106,"role":102,"phone":23,"phoneExt":23,"email":23},"Hyun Cho, MD,PhD",{"facility":108,"status":47,"city":109,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Chonnam National University Hospital, Chonnam National University Medical School","Gwangju",{"type":51,"coordinates":111},[112,113],126.91556,35.15472,{"lat":113,"lon":112},[116,119,120,121,122],{"name":117,"role":37,"phone":23,"phoneExt":23,"email":118},"Young Joon Hong, MD, PhD","hyj200@hanmail.net",{"name":41,"role":37,"phone":42,"phoneExt":23,"email":43},{"name":117,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":41,"role":102,"phone":23,"phoneExt":23,"email":23},{"name":123,"role":102,"phone":23,"phoneExt":23,"email":23},"Joon Ho Ahn, MD, PhD",{"facility":125,"status":47,"city":126,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Chung-Ang University Gwangmyeong Hospital","Gwangmyeong",{"type":51,"coordinates":128},[129,130],126.86639,37.47722,{"lat":130,"lon":129},[133,136,137,139],{"name":134,"role":37,"phone":23,"phoneExt":23,"email":135},"Sang Yeub Lee, MD, PhD","louisahj@gmail.com",{"name":134,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":138,"role":102,"phone":23,"phoneExt":23,"email":23},"Jun Hwan Cho, MD, PhD",{"name":140,"role":102,"phone":23,"phoneExt":23,"email":23},"Jinhwan Jo, MD, PhD",{"facility":142,"status":47,"city":143,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Catholic Kwandong University International St. Mary's Hospital","Incheon",{"type":51,"coordinates":145},[146,147],126.70515,37.45646,{"lat":147,"lon":146},[150,153],{"name":151,"role":37,"phone":23,"phoneExt":23,"email":152},"Hyung-Bok Park, MD, PhD","hyungbok7@gmail.com",{"name":151,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":155,"status":47,"city":143,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":156,"geoPoint":158,"contacts":159},"Gachon Cardiovascular Research Institute, Gachon University",{"type":51,"coordinates":157},[146,147],{"lat":147,"lon":146},[160,163],{"name":161,"role":37,"phone":23,"phoneExt":23,"email":162},"Albert Youngwoo Jang, MD, PhD","albert.jang.md@gmail.com",{"name":161,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":165,"status":47,"city":143,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":166,"geoPoint":168,"contacts":169},"Inha University Hospital",{"type":51,"coordinates":167},[146,147],{"lat":147,"lon":146},[170,173,174],{"name":171,"role":37,"phone":23,"phoneExt":23,"email":172},"Sang Don Park, MD, PhD","denki1@inha.ac.kr",{"name":171,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":175,"role":102,"phone":23,"phoneExt":23,"email":23},"Sung-Hwan Choi, MD, PhD",{"facility":177,"status":47,"city":178,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Chonbuk National University Hospital and Chonbuk National University Medical School","Jeonju",{"type":51,"coordinates":180},[181,182],127.14889,35.82194,{"lat":182,"lon":181},[185,188,189],{"name":186,"role":37,"phone":23,"phoneExt":23,"email":187},"Yisik Kim, MD, PhD","dr.kimesik@gmail.com",{"name":186,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":190,"role":102,"phone":23,"phoneExt":23,"email":23},"Chang Hoon Kim, MD, PhD",{"facility":192,"status":47,"city":193,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"Gyeongsang National University Hospital","Jinju",{"type":51,"coordinates":195},[196,197],128.08472,35.19278,{"lat":197,"lon":196},[200,203,206,207,208],{"name":201,"role":37,"phone":23,"phoneExt":23,"email":202},"Hangyul Kim, MD, PhD","13medicine@naver.com",{"name":204,"role":37,"phone":23,"phoneExt":23,"email":205},"Jin-Sin Koh, MD, PhD","kjs0175@gmail.com",{"name":201,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":204,"role":102,"phone":23,"phoneExt":23,"email":23},{"name":209,"role":102,"phone":23,"phoneExt":23,"email":23},"Min Gyu Kang, MD, PhD",{"facility":211,"status":47,"city":212,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Chung-Ang University Hospital","Seoul",{"type":51,"coordinates":214},[215,216],126.9784,37.566,{"lat":216,"lon":215},[219,222],{"name":220,"role":37,"phone":23,"phoneExt":23,"email":221},"Ho Youn Won, MD, PhD","nowhy@cau.ac.kr",{"name":220,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":224,"status":47,"city":212,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":225,"geoPoint":227,"contacts":228},"Kangbuk Samsung Hospital",{"type":51,"coordinates":226},[215,216],{"lat":216,"lon":215},[229,232,235,236,237],{"name":230,"role":37,"phone":23,"phoneExt":23,"email":231},"Jong-Young Lee, MD, PhD","jyleeheart@naver.com",{"name":233,"role":37,"phone":23,"phoneExt":23,"email":234},"Seung-Jae Lee, MD, PhD","sjjy1028@daum.net",{"name":230,"role":102,"phone":23,"phoneExt":23,"email":23},{"name":233,"role":102,"phone":23,"phoneExt":23,"email":23},{"name":238,"role":34,"phone":23,"phoneExt":23,"email":23},"Woochan Kwon, MD, PhD",{"facility":240,"status":47,"city":212,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":241,"geoPoint":243,"contacts":244},"Korea University Guro Hospital",{"type":51,"coordinates":242},[215,216],{"lat":216,"lon":215},[245,248],{"name":246,"role":37,"phone":23,"phoneExt":23,"email":247},"Dong-Oh Kang, MD, PhD","gelly9@naver.com",{"name":246,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":5,"status":47,"city":212,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":250,"geoPoint":252,"contacts":253},{"type":51,"coordinates":251},[215,216],{"lat":216,"lon":215},[254,256,259,260,262,264,266,267],{"name":33,"role":37,"phone":38,"phoneExt":23,"email":255},"drone80@hanmal.net",{"name":257,"role":37,"phone":38,"phoneExt":23,"email":258},"David Hong, MD","hongdawi@naver.com",{"name":33,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":261,"role":102,"phone":23,"phoneExt":23,"email":23},"Ki Hong Choi, MD, PhD",{"name":263,"role":102,"phone":23,"phoneExt":23,"email":23},"Taek Kyu Park, MD, PhD",{"name":265,"role":102,"phone":23,"phoneExt":23,"email":23},"Jeong Hoon Yang, MD, PhD",{"name":31,"role":102,"phone":23,"phoneExt":23,"email":23},{"name":28,"role":102,"phone":23,"phoneExt":23,"email":23},{"facility":269,"status":47,"city":212,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":270,"geoPoint":272,"contacts":273},"SMG-SNU Boramae Medical Center",{"type":51,"coordinates":271},[215,216],{"lat":216,"lon":215},[274,277],{"name":275,"role":37,"phone":23,"phoneExt":23,"email":276},"Hyun Sung Joh, MD, PhD","wingx4@naver.com",{"name":275,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":279,"status":47,"city":280,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Ajou University School of Medicine","Suwon",{"type":51,"coordinates":282},[283,284],127.00889,37.29111,{"lat":284,"lon":283},[287,290],{"name":288,"role":37,"phone":23,"phoneExt":23,"email":289},"Hong-Seok Lim, MD, PhD","hslimmd@hanmail.net",{"name":288,"role":34,"phone":23,"phoneExt":23,"email":23},{"facility":292,"status":47,"city":293,"state":23,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Uijeongbu St. Mary Hospital","Uijeongbu-si",{"type":51,"coordinates":295},[296,297],127.0474,37.7415,{"lat":297,"lon":296},[300,303,306,307],{"name":301,"role":37,"phone":23,"phoneExt":23,"email":302},"Seonghyeon Bu, MD, PhD","buseonghyeon@gmail.com",{"name":304,"role":37,"phone":23,"phoneExt":23,"email":305},"Chan Joon Kim, MD, PhD","godandsci@naver.com",{"name":301,"role":34,"phone":23,"phoneExt":23,"email":23},{"name":304,"role":102,"phone":23,"phoneExt":23,"email":23},{"type":34,"investigatorFullName":309,"investigatorTitle":310,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Joo Myung Lee","Associate Professor",[312],{"name":313,"class":6},"Chonnam National University Hospital","100573180","drug-coated-balloon-versus-drug-eluting-stent-for-treatment-of-de-novo-coronary-lesions-in-patients-with-high-bleeding-risk-2-100573180",false,"NCT06742931","Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2","Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease","DCB-HBR-2","Inclusion Criteria:\n\n1. Subject must be at least 19 years of age\n2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.\n3. Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty\n4. Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \\\u003C11 g\u002Fdl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated \\\u003C 3 years F. Planned daily NSAID (other than aspirin) or steroids for \\>30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance \\\u003C40 ml\u002Fmin or on dialysis I. Hematological disorders (platelet count \\\u003C100,000\u002Fmm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons\n5. Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure.\n6. No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure.\n\nExclusion Criteria:\n\n1. Patients unable to provide consent\n2. Patients with acute myocardial infarction or unstable angina\n3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB\n4. Patients with indication of oral anticoagulant\n5. Patients with concomitant drug-eluting stent implantation during index PCI\n6. Patients with history of ischemic stroke or previous myocardial infarction\n7. Patients with peripheral arterial occlusive disease\n8. Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (\\>70% diameter stenosis or FFR≤0.80)\n9. Patients who have non-cardiac co-morbid conditions with life expectancy \\\u003C1 year\n10. Patients who may result in protocol non-compliance (site investigator's medical judgment)\n11. Patients with cardiogenic shock or cardiac arrest\n12. Patients with severe left ventricular systolic dysfunction (ejection fraction \\\u003C30%)\n13. Patients with severe valvular heart disease requiring open heart surgery\n14. Pregnant or lactating women","ALL","19 Years",{"count":325,"type":326},1200,"ESTIMATED","INTERVENTIONAL",[329],"NA","A prospective, multi-center, open-label, randomized controlled, and superiority trial. The trial will compare clinical outcomes between discontinuation of antiplatelet agent and continuation of antiplatelet agent in HBR patients with chronic coronary syndrome treated by DCB angioplasty and standard duration of DAPT, followed by maintenance of single antiplatelet agent without clinical event for at least 1 year from the index procedure.",[332],"Chronic Coronary Syndrome",[334,335,336,337,338],"Coronary artery stenosis","Antiplatelet agent","Drug-coated balloon","Chronic coronary syndrome","Prognosis","2025-11-21",{"date":341,"type":342},"2025-11-28","ACTUAL",{"date":344,"type":342},"2025-04-07",{"date":346,"type":326},"2031-12-31",{"name":5,"class":6},18]