New hope for tough-to-treat stroke? tirofiban tested in 516 patients

NCT ID NCT06037889

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

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

Summary

This study tested whether a powerful blood thinner called tirofiban can improve recovery in people with a specific type of stroke called branch atheromatous disease (BAD). BAD strokes often get worse quickly and have few good treatments. The trial enrolled 516 adults within 48 hours of stroke onset. Half received tirofiban plus standard care, and half received standard care alone. The main goal was to see if more people in the tirofiban group could return to near-normal function (no or minimal disability) after 90 days.

What this could mean

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

Active substance: Tirofiban (a blood-thinning drug given through a vein)
What this could lead to: If it works, this could offer a more effective treatment for a type of stroke that often leads to rapid worsening and poor recovery.
What could go wrong: This is a completed Phase 3 trial, but results are not yet published. Tirofiban increases bleeding risk, which could outweigh benefits. The benefit may be small or 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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

516 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2026

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 75 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. Age: 18-75 years old 2. Acute ischemic stroke 3. Time from onset to randomization ≤48h; if onset time is unknown, time from last known well to randomization ≤48h 4. Meet the following BAD Diagnostic Imaging Criteria 4.1. DWI infarcts: single (isolated) deep (subcortical) infarcts; 4.2. The culprit arteries are either Lenticulostriate artery (LSA) or Paramedian pontine artery (PPA), and the infarct lesion on DWI conforms to one of the following characteristics (A/B): A. LSA: 1) "Comma-like" infarct lesions with "Fan-shaped" extension from bottom to top in the coronal plane; or 2) ≥ 3 layers (layer thickness 5-7 mm) on axial DWI brain images; B. PPA: The infarct lesion extends from the deep pons to the ventral pons on the axial DWI brain images; 4.3. No more than 50% stenosis on the parent artery of the criminal artery (i.e. corresponding basilar or middle cerebral artery) (Confirmed by magnetic resonance angiography \[MRA\] or computed tomography angiography \[CTA\] or digital substraction angiography \[DSA\]). 5. Singed informed consent by the patient or legally authorized representatives. Exclusion Criteria: 1. Transient ischemic attack (TIA) 2. Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space-occupying lesions, or other non-ischemic intracranial lesions detected by baseline CT/MRI, or MRA/CTA/DSA; 3. Presence of ≥50% stenosis in extracranial artery in tandem relationship ipsilateral to the lesion; 4. Cardiogenic embolism: atrial fibrillation, myocardial infarction, heart valve disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats per minute 5. Have received or plan to receive endovascular therapy or thrombolysis after onset; 6. Stroke of other clear causes, e.g., moyamoya disease, arterial dissection, vasculitis, etc. 7. modified Rankin Scale ≥2 before onset 8. Use of tirofiban within 1 week before or after onset 9. Low platelets (\<100×10\^9 /L), or Prothrombin time \>1.3 times of the upper normal limit, or INR \>1.5, or other systemic hemorrhagic tendencies such as hematologic disorders 10. Elevation of ALT or AST more than 1.5 times the upper normal limit; 11. Glomerular filtration rate \<60 ml/min/1.73m\^2 12. Known malignant tumors 13. History of trauma or major surgical intervention within 6 weeks prior to onset 14. History of intracranial hemorrhage 15. Active or recent history(within 30 days prior to onset) of clinical bleeding (e.g., gastrointestinal bleeding) 16. Malignant hypertension (systolic blood pressure \>200 mmHg, or diastolic blood pressure \>120 mmHg) 17. Life expectancy ≤ 6 months 18. Contraindications of 3 T MRI examination 19. Pregnant or lactating women 20. Have participated in another clinical trial within 3 months prior to the date of informed consent, or are participating in another clinical trial.

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Conditions

The condition(s) this trial relates to.

atherosclerosis stroke disorder

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 Hospital of Chifeng University

Chifeng, Hebei, 024099, China
Beijing Shijitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China
Beijing Shunyi Hospital

Beijing, Beijing Municipality, 101300, China
Botou City Hospital

Botou, Hebei, China
Cangzhou Central Hospital

Cangzhou, Hebei, China
Chengde Central Hospital

Chengde, Hebei, 067024, China
Deyang People's Hospital

Deyang, Sichuan, 618099, China
Hengshui People's Hospital

Hengshui, Hebei, 053099, China
Jinan Central Hospital

Jinan, Shandong, 250013, China
Meihekou Central Hospital

Meihekou, Jilin, 135022, China
Mianyang Central Hospital

Mianyang, Sichuan, 621099, China
North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, 063000, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China
Shengli Oilfield Central Hospital

Dongying, Shandong, 257099, China
The First Affiliated Hospital of Xinxiang Medical Unversity

Xinxiang, Henan, 453100, China
The First Hospital of Tsinghua University

Beijing, Beijing Municipality, China
The First People's Hospital of Shangqiu

Shangqiu, Henan, 476005, China
The First People's Hospital of Yibin

Yibin, Sichuan, 644000, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China
The Second Hospital of Tianjin Medical University

Tianjing, Tianjing, 300211, China
The Second People's Hospital of Yibin

Yibin, Sichuan, 644000, China
The second hospital of Baoding

Baoding, Hebei, 071051, China
Tibet Autonomous Region People's Hospital

Lhasa, Tibet, 850000, China
Xuzhou Central Hospital

Xuzhou, Jiangsu, 221009, China
Yellow River SANMENXIA Hospital

Sanmenxia, Henan, China

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