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Could heart patients ditch blood thinners after a year? new trial investigates

NCT ID NCT06742931

Disease control Sponsor: Samsung Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether people with chronic heart disease and a high risk of bleeding can stop taking antiplatelet drugs (blood thinners) one year after a balloon angioplasty procedure. Researchers will compare those who stop versus those who continue the medication, tracking major bleeding events and heart-related outcomes over time. The trial aims to enroll 1,200 participants across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antiplatelet agent discontinuation (no drug given; intervention is stopping medication)
What this could lead to
If successful, this could show that some heart patients can safely stop taking blood thinners after a year, lowering their risk of serious bleeding.
What could go wrong
This is an early-stage trial with no phase designation, and stopping blood thinners might increase the risk of heart attacks or clots. Results may not apply to all patients.

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 1,200 people

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

Started

Apr 2025

Expected to finish

Dec 2031

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. Subject must be at least 19 years of age 2. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. 3. Patients with chronic coronary syndrome and at least one de novo lesion of reference vessel size ≥2.25 mm, treated with DCB angioplasty 4. Patients with high bleeding risk: one or more of the criteria listed A. Age ≥ 75 years old B. Baseline Hemoglobin \<11 g/dl (or anemia requiring transfusion during the 4 weeks prior to randomization) C. Any prior intra-cerebral bleed D. Hospital admission for bleeding during the prior 12 months E. Non skin cancer diagnosed or treated \< 3 years F. Planned daily NSAID (other than aspirin) or steroids for \>30 days after PCI G. Planned surgery that would require interruption of DAPT (within next 12 months) H. Renal failure defined as calculated creatinine clearance \<40 ml/min or on dialysis I. Hematological disorders (platelet count \<100,000/mm3 or any coagulation disorder) J. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice K. Expected non-compliance to secondary prevention medications after PCI for other medical reasons 5. Patients who completed standard duration of DAPT (1-3months) and followed by maintenance of single antiplatelet agent (aspirin or P2Y12 inhibitor) for at least 1 year from index procedure. 6. No bleeding (BARC 2, 3, or 5 bleeding) or ischemic events (cardiovascular death, non-fatal MI, or clinically-indicated repeat revascularization) for at least 1 year from index procedure. Exclusion Criteria: 1. Patients unable to provide consent 2. Patients with acute myocardial infarction or unstable angina 3. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of DCB 4. Patients with indication of oral anticoagulant 5. Patients with concomitant drug-eluting stent implantation during index PCI 6. Patients with history of ischemic stroke or previous myocardial infarction 7. Patients with peripheral arterial occlusive disease 8. Patients with angiographic findings of A. Left main coronary artery disease B. In-stent restenosis is the cause of target lesion C. Target lesion in bypass graft D. True bifurcation lesion that requires upfront 2-stenting E. Patients with residual stenosis on non-target vessels after PCI (\>70% diameter stenosis or FFR≤0.80) 9. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 10. Patients who may result in protocol non-compliance (site investigator's medical judgment) 11. Patients with cardiogenic shock or cardiac arrest 12. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 13. Patients with severe valvular heart disease requiring open heart surgery 14. Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

coronary stenosis

As listed by the trial registrant

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

Chronic coronary syndrome

How to take part

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

  1. The places running it

    18 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

  • Ajou University School of Medicine

    RECRUITING

    Suwon, South Korea

  • Catholic Kwandong University International St. Mary's Hospital

    RECRUITING

    Incheon, South Korea

  • Chonbuk National University Hospital and Chonbuk National University Medical School

    RECRUITING

    Jeonju, South Korea

  • Chonnam National University Hospital, Chonnam National University Medical School

    RECRUITING

    Gwangju, South Korea

  • Chung-Ang University Gwangmyeong Hospital

    RECRUITING

    Gwangmyeong, South Korea

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, South Korea

  • Gachon Cardiovascular Research Institute, Gachon University

    RECRUITING

    Incheon, South Korea

  • Gangneung Asan Hospital, University of Ulsan College of Medicine

    RECRUITING

    Gangneung, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, South Korea

  • Ilsan Paik hospital

    RECRUITING

    Goyang, South Korea

  • Inha University Hospital

    RECRUITING

    Incheon, South Korea

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Ansan Hospital

    RECRUITING

    Ansan, South Korea

  • Korea University Guro Hospital

    RECRUITING

    Seoul, South Korea

  • SMG-SNU Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Uijeongbu St. Mary Hospital

    RECRUITING

    Uijeongbu-si, South Korea

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