Discontinuation of Antiplatelet Therapy After Drug-Coated Balloon Treatment

NCT07398001 | Not Yet Recruiting DMC

• 1 other identifier: 2025-04-042
• Study Type: interventional
• Target: 1,042
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Antiplatelet Therapy; Drug-coated Balloon; Percutaneous Coronary Intervention

Keywords

coronary artery disease; drug-coated balloon; percutaneous coronary intervention; antiplatelet therapy; clinical outcomes

Outcome Measures

Primary Outcomes (1)

• Net adverse clinical events (NACE)

  A composite of all-cause death, non-fatal myocardial infarction, clinically driven target vessel revascularization, and bleeding defined as Bleeding Academic Research Consortium (BARC) type 2 to 5. Non-fatal myocardial infarction is defined as a myocardial infarction diagnosed using standard clinical, electrocardiographic, and biomarker criteria that does not result in death.

  Up to 12 months after randomization

Secondary Outcomes (10)

• NACE

  Up to 24, 36 months after randomization

• The single components of the primary endpoint

  Up to 12, 24, 36 months after randomization

• Rate of cardiac death

  Up to 12, 24, 36 months after randomization

• Stroke (ischemic and hemorrhagic)

  Up to 12, 24, 36 months after randomization

• Target lesion failure

  Up to 12, 24, 36 months after randomization

Study Arms (2)

Stop Antiplatelet

EXPERIMENTAL

Antiplatelet discontinuation group

Drug: Stop Antiplatelet

Continue Antiplatelet

ACTIVE COMPARATOR

Antiplatelet continuation group

Drug: Continue Antiplatelet

Interventions

Stop Antiplatelet DRUG

Antiplatelet discontinuation after DCB treatment

Stop Antiplatelet

Continue Antiplatelet DRUG

Antiplatelet continuation after DCB treatment

Continue Antiplatelet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulsan University Hospital: lead

Study Sites (7)

Korea University Ansan Hospital

Ansan, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Kosin University Hospital

Pusan, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Ulsan Medical Center

Ulsan, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Eun-Seok Shin, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: February 9, 2026
• Study Start: February 12, 2026
• Primary Completion (Estimated): February 11, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• Access Criteria: Researchers who provide a methodologically sound research proposal may request access to the de-identified individual participant data. Requests will be reviewed by the study steering committee, and access will be granted following approval of the proposal and execution of a data use agreement.

Locations

KR (7)