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Heart patients may ditch blood thinners after one year, major trial investigates

NCT ID NCT07398001

Disease control Sponsor: Ulsan University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people who had a heart procedure with a drug-coated balloon can safely stop taking antiplatelet drugs after 12 months. The goal is to see if stopping reduces bleeding risks while keeping the heart protected. About 1,000 adults who have been event-free for a year will be randomly assigned to stop or continue their medication and followed for outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,042 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Patients who underwent drug-coated balloon treatment at least 12 months prior to enrollment. 3. Patients who have not experienced major adverse cardiovascular events, including myocardial infarction, stroke, or target vessel revascularization, since the index DCB treatment. 4. Patients who have not experienced major bleeding since the index DCB treatment. 5. Patients who are receiving antiplatelet therapy at the time of enrollment. Exclusion Criteria: 1. Patients with concomitant vascular disease requiring long-term antiplatelet therapy. 2. 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. 3. Patients who are participating in another drug or coronary device clinical study at the time of enrollment.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Antiplatelet therapy Drug coated balloon Percutaneous coronary intervention

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kangwon National University Hospital

    Chuncheon, South Korea

  • Korea University Ansan Hospital

    Ansan, South Korea

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kosin University Hospital

    Pusan, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Ulsan Medical Center

    Ulsan, South Korea

  • Ulsan University Hospital

    Ulsan, South Korea

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