HR-MRI–Directed Tirofiban Therapy for Late-Window ICAS-LAA Stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial uses high-resolution vessel wall MRI to precisely classify stroke cause in adults with anterior circulation AIS and ICAS-LAA. Eligible participants are treated beyond 24 hours up to 7 days after onset with tirofiban and dual antiplatelet therapy, and decisions are guided by HR-MRI findings. The study assesses safety and effectiveness of this approach in a late-window setting, aiming to generate high-quality evidence for this strategy. Imaging-informed selection aims to distinguish ICAS-LAA from other etiologies such as cardiogenic embolism. Primary outcomes include safety signals and functional outcomes, with rigorous monitoring for hemorrhagic and vascular events.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Acute ischemic stroke (AIS) in the anterior intracranial circulation (internal carotid artery system) confirmed by clinical symptoms and imaging examinations;
3. Time from symptom onset or last known normal state to randomization: \> 24 hours and ≤ 7 days;
4. Stroke subtype confirmed as intracranial large artery atherosclerosis (ICAS) by high-resolution vessel wall imaging (HR-VWI) according to the TOAST classification, with cardiogenic embolism and other etiologies excluded;
5. Baseline National Institutes of Health Stroke Scale (NIHSS) score of 4-20 at the time of randomization;
6. Signed informed consent form obtained from the patient or their legal representative.

Exclusion Criteria:

1. Planned to receive reperfusion therapy (endovascular therapy or intravenous thrombolysis)；
2. Intracranial hemorrhage confirmed by computed tomography (CT)；
3. Definite or suspected cardiogenic embolism；
4. History of atrial fibrillation or current electrocardiogram indicating atrial fibrillation；
5. Acute ischemic stroke caused by other etiologies, such as Moyamoya disease, arterial dissection, arteritis, etc；
6. Imaging examinations indicating that the area of the current cerebral infarction exceeds 1/2 of the area of a single cerebral lobe;
7. Known contraindications to antiplatelet therapy, including hematochezia, gastrointestinal bleeding, or any other hemorrhagic disorders;
8. History of hypersensitivity to aspirin;
9. Definite indication for anticoagulant therapy expected during the study period (e.g., atrial fibrillation, mechanical heart valve, deep vein thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state, etc.);
10. Complicated with malignant tumors, chronic hemodialysis, severe renal insufficiency (glomerular filtration rate \[GFR\] \< 30 ml/min or serum creatinine \[Cr\] \> 220 μmol/L (2.5 mg/dl)), or severe hepatic insufficiency (serum alanine aminotransferase \[ALT\] \> 2 times the upper limit of normal \[ULN\], or serum aspartate aminotransferase \[AST\] \> 2 times the ULN);
11. Severe heart failure (New York Heart Association \[NYHA\] Functional Classification Class III or IV);
12. Complicated with severe non-cardiovascular comorbidities, with an estimated survival time \< 6 months;
13. Concurrent new cerebral infarction in both anterior and posterior circulations;
14. Inability to complete the follow-up procedures;
15. Presence of other known neurological disorders that may complicate the follow-up;
16. Concurrent participation in other therapeutic clinical trials with incomplete treatment and follow-up;
17. Other conditions that the investigators consider inappropriate for enrollment in this study.

Where it's running

• Weifang People's Hospital
  Weifang, China/Shandong Province, China Recruiting

Study contacts

• Study coordinator: Weili Li, MD
• Email: wfsrmyy_ky@163.com
• Phone: 86-0536-8192680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.