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
Samsung Medical Center
1,200 participants
Apr 7, 2025
INTERVENTIONAL
Conditions
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
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
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)
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NCT06742931