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Shorter blood thinner combo may cut bleeding risk in heart patients

NCT ID NCT05418556

Disease control Sponsor: Asan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 6 times

Summary

This study tests whether a personalized blood-thinner plan can reduce bleeding in people with coronary artery disease who have received a heart stent. About 3,944 participants will either get the usual dual antiplatelet therapy (two blood thinners) or a shorter course followed by just one drug. The goal is to see if the tailored approach causes less bleeding while still preventing heart attacks and stent problems.

What this could mean

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

Active substance
aspirin, clopidogrel, prasugrel, ticagrelor
What this could lead to
If successful, this could lead to a safer antiplatelet strategy that lowers bleeding risk while still preventing heart attacks and stent blockages.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the tailored approach may not prove safer or could increase the risk of blood 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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,944 people

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

Started

Oct 2022

Expected to finish

Dec 2032

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. Men or women ≥19 years 2. Typical chest pain or objective evidence of myocardial ischemia suitable for PCI 3. Significant de novo coronary artery lesions suitable for DES implantation 4. Patients who underwent optimized stent implantation either by IVUS or OCT * Using IVUS * MSA \>5.5 mm2, or MSA \>90% of the MLA at the distal reference segment * Plaque burden \<50% with 5 mm of both stent edge * No edge dissection; thrombus or plaque protrusion occupying \< 10% of the stent area * Using OCT * MSA \>4.5 mm2, or MSA \>90% of the MLA at the distal reference segment * No significant malapposition * No significant edge dissection†; thrombus or plaque protrusion occupying \< 10% of the stent area (\*Significant malapposition is defined as strut separation ≥ 0.3 mm from the vessel wall extending over a length \> 3 mm. †Significant dissection is defined as a dissection penetrating the medial layer and extending over more than one quadrant.) 5. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site Exclusion Criteria: 1. Angiographic exclusion criteria: any of the followings 1. Bypass graft lesions 2. Lesions in which impaired delivery of imaging catheters is expected: * Extreme angulation (≥90°) proximal to or within the target lesion. * Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion. * Heavy calcification proximal to or within the target lesion. 2. In-stent restenosis 3. Hypersensitivity or contraindication to device material and its degradants and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. 4. Persistent thrombocytopenia (platelet count \<80,000/μl) 5. Any history of hemorrhagic stroke or intracranial hemorrhage / TIA or ischemic stroke within the past 6 months 6. A known intolerance or hypersensitivity to a study drug (aspirin, clopidogrel or ticagrelor) or heparin 7. Patients requiring long-term oral anticoagulants or cilostazol 8. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure. 9. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer. 10. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study. 11. History of liver cirrhosis (Child-Pugh B or C) or biliary tract obstruction 12. Life expectancy \< 1 years for any non-cardiac or cardiac causes 13. Cardiogenic shock at the index admission 14. Patient's pregnant or breast-feeding 15. Active bleeding or extreme-risk for major bleeding (e.g. active peptic ulcer disease, gastrointestinal pathology with a high risk for bleeding, malignancies with a high risk for bleeding) 16. Unwillingness or inability to comply with the procedures described in this protocol.

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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.

Coronary artery disease

How to take part

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

  1. The places running it

    32 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 Hospital

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Bucheon Sejong Hospital

    RECRUITING

    Bucheon-si, South Korea

  • Chungbuk National University Hospital

    RECRUITING

    Chungju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Jungnam, South Korea

  • Chungnam National University Sejong Hospital

    RECRUITING

    Jungnam, South Korea

  • Daegu Catholic Univ Medical Center

    NOT_YET_RECRUITING

    Daegu, South Korea

  • Dankook University Hospital

    RECRUITING

    Jungnam, South Korea

  • Dong-A University Hospital

    RECRUITING

    Busan, South Korea

  • Dongkang Hospital

    NOT_YET_RECRUITING

    Ulsan, South Korea

  • Gangneung Asan Hospital

    RECRUITING

    Gangneung, South Korea

  • Gyeongsang National University Changwon Hospital

    RECRUITING

    Changwon, South Korea

  • Gyeongsang National University Hospital

    RECRUITING

    Jinju, South Korea

  • Hallym Univ. Medical Center.

    NOT_YET_RECRUITING

    Hwaseong-si, South Korea

  • Inje University Busan Paik Hospital

    NOT_YET_RECRUITING

    Busan, South Korea

  • Inje University Haeundae Paik Hospital

    NOT_YET_RECRUITING

    Busan, South Korea

  • Jeju National University Hospital

    RECRUITING

    Jeju City, South Korea

  • Jeonbuk National University Hospital

    RECRUITING

    Jeonju, South Korea

  • Kangbuk Samsung Hospital

    RECRUITING

    Seoul, South Korea

  • Kangwon National University Hospital

    RECRUITING

    Chuncheon, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Kosin University Gospel Hospital

    RECRUITING

    Busan, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, South Korea

  • Pusan National University Yangsan Hospital

    NOT_YET_RECRUITING

    Yangsan, South Korea

  • The Catholic University of Korea, Daejeon ST. Mary's Hospital

    RECRUITING

    Daejeon, South Korea

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, ST. Vincent's Hospital

    COMPLETED

    Suwon, South Korea

  • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

    NOT_YET_RECRUITING

    Uijeongbu-si, South Korea

  • Ulsan University Hospital

    RECRUITING

    Ulsan, South Korea

  • Veterans Hospital

    RECRUITING

    Daegu, South Korea

  • Veterans Hospital Service Medical Center

    RECRUITING

    Seoul, South Korea

  • dongguk University Medical Center

    NOT_YET_RECRUITING

    Ilsan, South Korea

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