Not Yet RecruitingNot Applicable

Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment

South Korea1,042 participantsStarted 2026-02-12

Plain-language summary

The goal of this clinical trial is to evaluate the benefits and risks of discontinuing antiplatelet therapy on clinical outcomes in patients who previously underwent coronary intervention using a drug-coated balloon. The main questions it aims to answer are: Does stopping antiplatelet therapy after 12 months affect the risk of net adverse clinical events? Does stopping antiplatelet therapy reduce the risk of bleeding compared with continuing treatment? Researchers will compare patients who discontinue antiplatelet therapy with patients who continue antiplatelet therapy to determine the impact on clinical outcomes during follow-up. Participants will: Be randomly assigned to either discontinue or continue antiplatelet therapy Receive routine clinical follow-up through clinic visits or telephone contacts Be monitored for cardiovascular events and bleeding outcomes over time

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. Adults aged 19 years or older who are able to understand the risks, benefits, and treatment alternatives of the study and who provide written informed consent voluntarily.
✓. Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment.
✓. Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment.
✓. Patients who have not experienced major bleeding since the index DCB treatment.
✓. Patients who are receiving antiplatelet therapy at the time of enrollment.

Exclusion criteria

✕. Patients with concomitant vascular disease requiring long-term antiplatelet therapy.
✕. Patients with non-cardiac comorbid conditions that, in the judgment of the investigator, are associated with a life expectancy of less than 1 year or may result in poor compliance with the study protocol.
✕. Patients who are participating in another drug or coronary device clinical study at the time of enrollment.

What they're measuring

Net adverse clinical events (NACE)

Timeframe: Up to 12 months after randomization

Trial details

NCT IDNCT07398001

SponsorUlsan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-11

Contact for this trial

Eun-Seok Shin, MD

+82-10-6319-4025 sesim1989@gmail.com

View on ClinicalTrials.gov More Percutaneous Coronary Intervention trials