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1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention
Sponsor: Ulsan University Hospital
Summary
This study will compare the clinical outcomes of a 1-month dual antiplatelet therapy (DAPT) strategy with a standard 6-month DAPT strategy in patients undergoing successful drug-coated balloon-only percutaneous coronary intervention (DCB-only PCI). The study will evaluate net adverse clinical events (NACE) at 12 months to assess whether short-term 1-month DAPT is non-inferior to 6-month DAPT. The study is a prospective, randomized, open-label, blinded-endpoint, multicenter trial.
Official title: 1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention (ADAPT-DCB)
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1258
Start Date
2026-10-19
Completion Date
2029-10-31
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
1-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 1 month (30 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 25 and 35, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.
6-Month DAPT
Patients receive dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) for 6 months (180 days) following successful drug-coated balloon-only percutaneous coronary intervention (PCI). Aspirin is discontinued between Days 166 and 194, after which patients transition to single antiplatelet therapy (P2Y12 inhibitor monotherapy) through 12 months.