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NOT YET RECRUITING
NCT07879430
NA

1-Month Versus 6-Month Dual Antiplatelet Therapy After Successful Drug-Coated Balloon-Only Percutaneous Coronary Intervention

Sponsor: Ulsan University Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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.