NCT07398001

Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,042 (estimated)
• Sponsor: Ulsan University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

Coronary artery disease is a major cause of morbidity and mortality worldwide. Percutaneous coronary intervention is widely used for the treatment of coronary artery disease, traditionally involving implantation of drug-eluting stents. Although contemporary drug-eluting stents have improved safety and efficacy compared with earlier stent technologies, permanent metallic implants remain associated with long-term considerations, including restenosis, stent thrombosis, and the need for prolonged antiplatelet therapy. Drug-coated balloon therapy represents an alternative revascularization strategy that delivers an antiproliferative drug to the coronary vessel wall without implantation of a permanent scaffold. This "leave-nothing-behind" approach has been adopted in specific clinical settings and has been increasingly applied in selected coronary lesions. The absence of a permanent implant may offer potential advantages with respect to long-term vessel healing and antiplatelet therapy management. Bleeding complications after coronary intervention are clinically relevant and have been associated with adverse outcomes. Decisions regarding the duration of antiplatelet therapy require careful consideration of both ischemic and bleeding risks. While shorter durations of antiplatelet therapy have been explored following contemporary coronary interventions, optimal long-term antiplatelet strategies after drug-coated balloon-based procedures remain incompletely defined. Limited data are available regarding the clinical outcomes associated with discontinuation of antiplatelet therapy beyond 12 months in patients who have undergone initial percutaneous coronary intervention using drug-coated balloon treatment and have remained clinically stable. As a result, uncertainty persists regarding the balance of potential benefits and risks of long-term antiplatelet therapy in this population. This prospective, randomized, multicenter study is designed to compare clinical outcomes between patients who discontinue antiplatelet therapy and those who continue antiplatelet therapy after 12 months following drug-coated balloon-based percutaneous coronary intervention. The study aims to provide additional evidence to inform clinical decision-making regarding antiplatelet therapy management in patients treated with drug-coated balloons.

Conditions

• Percutaneous Coronary Intervention
• Antiplatelet Therapy
• Drug-coated Balloon

Interventions

Type	Name	Description
DRUG	Stop Antiplatelet	Antiplatelet discontinuation after DCB treatment
DRUG	Continue Antiplatelet	Antiplatelet continuation after DCB treatment

Timeline

• Start date: 2026-02-12
• Primary completion: 2028-02-11
• Completion: 2030-07-31
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

7 sites across 1 country: South Korea