Drug-Coated Balloon Versus Drug-Eluting Stent for Treatment of De-Novo Coronary Lesions in Patients With High Bleeding Risk-2
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Major bleeding (BARC 2, 3, or 5 bleeding) — 1 year after last patient enrollment
BARC 2, 3, or 5 bleeding
Trial sites (18)
| Facility | City | Region | Status |
|---|---|---|---|
| Korea University Ansan Hospital | Ansan | South Korea | Recruiting |
| Keimyung University Dongsan Medical Center | Daegu | South Korea | Recruiting |
| Gangneung Asan Hospital, University of Ulsan College of Medicine | Gangneung | South Korea | Recruiting |
| Ilsan Paik hospital | Goyang | South Korea | Recruiting |
| Chonnam National University Hospital, Chonnam National University Medical School | Gwangju | South Korea | Recruiting |
| Chung-Ang University Gwangmyeong Hospital | Gwangmyeong | South Korea | Recruiting |
| Catholic Kwandong University International St. Mary's Hospital | Incheon | South Korea | Recruiting |
| Gachon Cardiovascular Research Institute, Gachon University | Incheon | South Korea | Recruiting |
| Inha University Hospital | Incheon | South Korea | Recruiting |
| Chonbuk National University Hospital and Chonbuk National University Medical School | Jeonju | South Korea | Recruiting |
| Gyeongsang National University Hospital | Jinju | South Korea | Recruiting |
| Chung-Ang University Hospital | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| SMG-SNU Boramae Medical Center | Seoul | South Korea | Recruiting |
| Ajou University School of Medicine | Suwon | South Korea | Recruiting |
| Uijeongbu St. Mary Hospital | Uijeongbu-si | South Korea | Recruiting |
More Samsung Medical Center trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06742931 on ClinicalTrials.gov ↗ ← All trials in South Korea