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Heart patients may need only one blood thinner after balloon treatment, major trial tests

NCT ID NCT07587099

Disease control Sponsor: Gan Lijun 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 4 times

Summary

This study looks at whether taking just one blood thinner (a P2Y12 inhibitor) is as safe and effective as taking two blood thinners (dual antiplatelet therapy) for people with stable heart disease who have a drug-coated balloon procedure without a stent. About 2,170 adults will be followed for 12 months to see rates of serious heart events and bleeding. The goal is to find a simpler treatment that reduces bleeding risk while still protecting the heart.

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 2,170 people

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

Started

May 2026

Expected to finish

Dec 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

18 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: Subjects who successfully underwent percutaneous coronary intervention (PCI) with drug-coated balloon (DCB) treatment without stent implantation are eligible for inclusion in this study if Male and female patients who meet the following criteria： 1. Age ≥ 18 years. 2. target lesion in vessels with diameter ≥2.0 and ≤4.5 mm (visual estimation). 3. the total target vessels ≤2 and a total of target lesions ≤2. 4. Total length of DCB used for target lesions \<60 mm. 5. The subject's indication for PCI is chronic coronary syndrome (CCS) and stable Acute Coronary Syndrome (S-ACS), include Silent Ischemia, stable angina (SA), unstable angina (UA), non-ST-segment elevation myocardial (NSTEMI), or ST-segment elevation acute myocardial infarction (STEMI) with onset \>2 weeks. 6. All lesions were successfully treated with a drug-eluting balloon during routine clinical practice, i.e., post-procedural angiographic visual diameter stenosis \<30%. 7. At the operator's discretion, no flow-limiting angiographic complications requiring extension of dual antiplatelet therapy (DAPT)have occurred. 8. All PCI stages have been completed (if applicable), and no further PCI procedures are planned. Inclusion criteria at the randomization visit within 24 hours post-index PCI: At the time of the randomization visit (within 24 hours after successful drug-eluting balloon treatment during index PCI), the following criteria mustbe met: The subject must have had an uneventful clinical course within 24 hours post-index PCI, i.e., no myocardial infarction,symptomatic restenosis, device-related thrombus formation, stroke, or any revascularization procedure (coronary or non-coronary)requiring extension of dual antiplatelet therapy. Exclusion Criteria: Patients will be ineligible if they meet any of the following criteria: 1. Stent implantation within 6 months prior to index percutaneous coronary intervention (PCI). 2. Treatment for in-stent thrombosis (IST) at the time of index PCI or within 6 months prior to it. 3. Treatment with a bioabsorbable stent at any time prior to index PCI. 4. Acute myocardial infarction with ST-segment elevation within the past two weeks. 5. True bifurcation lesions requiring treatment with two stents (Medina 1,1,1/1,0,1/0,1,1) with a branch vessel diameter≥2.5 mm (visual estimation). 6. Chronic total occlusion of the target lesion (≥3 months). 7. Unprotected left main coronary artery. 8. Thrombus present in the target lesion (imaging/visual). 9. Total length of DCB used in the target lesion ≥60 mm. 10. Active bleeding requiring medical intervention (BARC ≥2) at the time of randomization. 11. Indications for long-term oral anticoagulation therapy. 12. Life expectancy of less than 1 year. 13. Known allergy or hypersensitivity to aspirin, clopidogrel, ticagrelor, or sirolimus. 14. Currently participating in another trial and has not yet reached the primary endpoint. 15. History of asthma induced by salicylates or substances with similar effects (particularly nonsteroidal anti-inflammatory drugs). 16. Pregnant or breastfeeding women. 17. Inability to understand and follow study-related instructions or to comply with the study protocol. 18. Inability to provide written informed consent

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder Coronary Disease

As listed by the trial registrant

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

Coronary heart disease (CHD)

How to take part

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

  1. The places running it

    14 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

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272029, China

  • Beijing Luhe Hospital Capital Medical University

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Heze Municipal Hospital

    NOT_YET_RECRUITING

    Heze, Shandong, China

  • Liaocheng People's Hospital

    NOT_YET_RECRUITING

    Liaocheng, Shandong, China

  • Qingdao Municipal Hospital

    NOT_YET_RECRUITING

    Qingdao, Shandong, China

  • Shandong Provincial Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Shandong Provincial Third Hospital

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Shanghai Fengxian District People's Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, China

  • Tai'an City Central Hospital

    NOT_YET_RECRUITING

    Tai’an, Shandong, China

  • The 2nd Affiliated Hospital of Harbin Medical University

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, China

  • The First Affiliated Hospital of Hainan Medical University

    NOT_YET_RECRUITING

    Haikou, Hainan, China

  • The First Affiliated Hospital of Xinjiang Medical University

    NOT_YET_RECRUITING

    Ürümqi, Xinjiang, China

  • The Second Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • Zaozhuang Municipal Hospital

    NOT_YET_RECRUITING

    Zaozhuang, Shandong, China

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