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New combo therapy may stop stroke from getting worse

NCT ID NCT05310968

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding a fast-acting blood thinner (tirofiban) to standard aspirin can prevent strokes from getting worse in people with small artery blockages in the brain. About 970 adults aged 18-80 who had a mild stroke within the last 48 hours took part. The goal was to see if the combination reduces the risk of another stroke or early worsening of symptoms.

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

970 people

The number who actually took part.

Started

Nov 2022

Finished

Sep 2025

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 to 80 years

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. 18-80 years old; 2. Male or female; 3. Within 48 hours of onset; 4. Clinical symptoms and signs suggest acute single infarction of penetrating artery territory (no cortical involvement, no multifocal involvement, NIHSS ≤10 and consciousness-1a ≤1); 5. DWI suggests single infarction (diameter \< 30mm) of penetrating artery territory which involves at least 2 axial layers, or its maximum diameter ≥15mm, or it is connected to the ventral surface of the pons, closing to but not crossing the midline, and located in one side; 6. No severe stenosis (defined as \<70%) of parent artery; 7. The patient or his / her legal representative is able and willing to sign the informed consent. Exclusion Criteria: 1. History of intracranial hemorrhage 2. History of intracranial tumors, cerebral arteriovenous malformation, or aneurysm; 3. Emergency endovascular intervention or intravenous thrombolysis before randomization; 4. Dual antiplatelet therapy currently or within 14 days of randomization (excluding use of aspirin and clopidogrel after onset without loading dose of clopidogrel); 5. Use of other antiplatelet drugs (ticagrelor, cilostazol, etc.), anticoagulant drugs, snake venom, defibrase, lumbrukinase or other defibrase treatments after onset; 6. Expected long-term use of non-investigational antiplatelet drugs or non-steroidal anti-inflammatory drugs; 7. With severe stenosis (\> 70%) of parent artery giving off responsible penetrating artery; 8. Definite indications for anticoagulation (suspicion of cardioembolism, e.g. atrial fibrillation, known heart valve prosthesis, atrial myxoma, endocarditis, etc.) or indications for dual antiplatelet therapy (e.g. recent coronary or cerebral artery stent implantation); 9. Severe hepatic or renal insufficiency before randomization (severe hepatic insufficiency refers to ALT or AST \> 3 times the upper limit of normal; severe renal insufficiency refers to creatinine clearance rate (CCr) \< 30ml/min); 10. Hemorrhagic tendency (including but not limited to)：PLT\<100×10\^9/L; heparin treatment within 48h; APTT ≥ 35s; current use of warfarin, INR \> 1.7; current use of novel oral anticoagulants; current use of direct thrombin or factor Xa inhibitor; 11. Resistant hypertension which could not be controlled by medicine (SBP \> 180mmHg or DBP \> 110mmHg); 12. History of obvious head trauma within three months of randomization; 13. History of intracranial or intramedullary surgery within three months of randomization; 14. History of major surgery or severe physical trauma within one month of randomization; 15. Severe neurological defects (mRS ≥ 2) before the onset; 16. Acute pericarditis; 17. Hemorrhagic retinopathy; 18. Childbearing-age women who do not take effective methods of contraception without negative records of pregnancy tests; 19. Known to be allergic to tirofiban; 20. Other surgical or interventional therapy planned within 3 months requiring experimental drugs discontinuation; 21. Life expectancy \< 6 months due to any terminal illness; 22. Patients who are undergoing experimental drugs or instruments; 23. Other conditions which suggest participants are unsuitable for this study, e.g. mental diseases, cognitive or mood disturbance,and could not comply with research procedures or with MRI contraindications.

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Conditions

The condition(s) this trial relates to.

atherosclerosis

As listed by the trial registrant

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

Branch atheromatous disease

Contacts and locations

Locations

  • Affiliated Nantong Hospital of Shanghai University (The Sixth People's Hospital of Nantong)

    Nantong, Jiangsu, China

  • Baotou Central Hospital

    Baotou, Inner Mongolia, China

  • Benxi Central Hospital

    Benxi, Liaoning, China

  • Changzhi People's Hospital

    Changzhi, Shanxi, China

  • China-Japan Union Hospital of Jilin University

    Changchun, Jilin, China

  • Guanxian People's Hospital

    Liaocheng, Shandong, China

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, China

  • Hejian People's Hospital

    Hejian, Hebei, China

  • Jincheng People's Hospital

    Jincheng, Shanxi, China

  • Jiyuan Hospital of Traditional Chinese Medicine

    Jiyuan, Henan, China

  • Liaocheng Central Hospital

    Liaocheng, Shandong, China

  • Mengzhou People's Hospital

    Henan, Henan, China

  • Ningjin People's Hospital

    Dezhou, Shandong, China

  • School of Medicine, Xiamen University

    Zhangzhou, Fujian, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, China

  • Shaodong People's Hospital

    Shaoyang, Hunan, China

  • Suixian Hospital of Traditional Chinese Medicine

    Shangqiu, Henan, China

  • Tanghe County People's Hospital

    Nanyang, Henan, China

  • Tangshan Gongren Hospital

    Tangshan, Hebei, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The Affiliated Shuyang Hospital of Xuzhou Medical University

    Suqian, Jiangsu, China

  • The First Affiliate Hospital of Baotou Medical College

    Baotou, Inner Mongolia, China

  • The First Hospital of Fangshan District Beijing

    Beijing, Beijing Municipality, China

  • The First People's Hospital of Nanyang

    Nanyang, Henan, China

  • The First People's Hospital of Xianyang

    Xianyang, Shaanxi, China

  • The People's Hospital of Biyang County

    Zhumadian, Henan, China

  • The People's Hospital of Gaotang County

    Liaocheng, Shandong, China

  • The People's Hospital of Linqing

    Linqing, Shandong, China

  • The People's Hospital of Qinghe County

    Xingtai, Hebei, China

  • The People's Hospital of Suxitong Science & Technology Inductrial Park

    Nantong, Jiangsu, China

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, China

  • The Second People's Hospital of Liaocheng

    Liaocheng, Shandong, China

  • The Third People's Hospital of Liaocheng

    Liaocheng, Shandong, China

  • Wanrong County People's Hospital

    Yuncheng, Shanxi, China

  • Weihai Wendeng District People's Hospital

    Weihai, Shandong, China

  • Xiuwu People's Hospital

    Jiaozuo, Henan, China

  • Zibo Municipal Hospital

    Zibo, Shandong, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.