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RECRUITING
NCT06742931
NA

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

View on ClinicalTrials.gov

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

Interventions

OTHER

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.

OTHER

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