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Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
Sponsor: Samsung Medical Center
Summary
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.
Official title: Discontinuation of Antiplatelet Agent After Drug-Coated Balloon Angioplasty in Stabilized Patients With High Bleeding Risk and Coronary Artery Disease
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2025-04-07
Completion Date
2031-12-31
Last Updated
2025-11-28
Healthy Volunteers
No
Conditions
Interventions
Discontinuation of antiplatelet agent group
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.
Continuation of antiplatelet agent group
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.
Locations (18)
Korea University Ansan Hospital
Ansan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Gangneung Asan Hospital, University of Ulsan College of Medicine
Gangneung, South Korea
Ilsan Paik hospital
Goyang, South Korea
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Catholic Kwandong University International St. Mary's Hospital
Incheon, South Korea
Gachon Cardiovascular Research Institute, Gachon University
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Chonbuk National University Hospital and Chonbuk National University Medical School
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Ajou University School of Medicine
Suwon, South Korea
Uijeongbu St. Mary Hospital
Uijeongbu-si, South Korea