Intravenous Tirofiban After Delayed Thrombolysis in Stroke

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Aug 1, 2025

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ClinConnect Summary

This clinical trial is studying whether a medicine called tirofiban, given through a vein, can help people who have had a type of stroke called an acute ischemic stroke. This stroke happens when blood flow to the brain is blocked. The trial focuses on patients who received a standard stroke treatment called intravenous thrombolysis (a clot-busting medicine) between 4.5 and 24 hours after their stroke started but do not have a large blocked artery. Researchers want to see if adding tirofiban is safe and if it helps improve recovery.

Adults aged 18 and older who had a stroke 4.5 to 24 hours ago and were treated with the clot-busting medicine may be eligible. To join, patients need to have a certain level of stroke symptoms (measured by a scale doctors use) and be able to start the study medicine within an hour after their initial treatment. People with bleeding in the brain, major artery blockages, certain heart problems, serious kidney issues, or allergies to the study drugs cannot participate. If you take part, you’ll receive either tirofiban or a placebo (a medicine with no active drug) without knowing which one, and doctors will carefully monitor you for any benefits or side effects. This study is not yet recruiting patients but aims to find better ways to help stroke patients recover when treatment starts later than usual.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged 18 years or older;
• • 2. Clinical diagnosed acute ischemic stroke (AIS) with last known well time of 4.5-24 hours;
• 3. Any of the following presentation of AIS:
• • 1) Treated with IVT followed by no significant change in neurological function; 2) Treated with IVT followed by early neurological deterioration; 4. NIHSS score ≥4 before randomization; 5. Able to receive the designated study drug within 60 minutes after IVT; 6. Written informed consent is obtained from patients and/or their legal representatives.
• Exclusion Criteria:
• • 1. Intracranial or subarachnoid hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI), or any intracranial hemorrhage history;
• • 2. CTA/MRA/DSA showed occlusion of the internal carotid artery, middle cerebral artery M1 or M2 segment, anterior cerebral artery A1 segment, and vertebrobasilar artery;
• • 3. Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction less than 30%;
• • 4. Pre-stroke modified Rankin scale (mRS)≥2;
• • 5. Renal insufficiency (glomerular filtration rate \< 30 mL/min or serum creatinine \> 220 μmol/L \[2.5 mg/dl\]);
• • 6. Pregnant or lactating women;
• • 7. NCCT, CTA source imaging, or MRI-DWI showing ASPECTS or PC-ASPECTS \< 6;
• • 8. Allergy to tirofiban, other glycoprotein IIb/IIIa inhibitors, aspirin or clopidogrel;
• • 9. History of bleeding disorder, severe heart, liver or kidney disease, or sepsis;
• • 10. Active bleeding diathesis, including clinical laboratory evidence of coagulation abnormalities (platelet count \< 100×10⁹/L, activated partial thromboplastin time \>50 seconds or international normalized ratio \> 1.7), or treatment with a direct oral anticoagulant within the prior 48h;
• • 11. CT or MR evidence of mass effect or intracranial tumor (except small meningioma);
• • 12. CT or MR angiography evidence of intracranial arteriovenous malformations or aneurysm;
• • 13. Severe allergy to contrast agents (non-mild rash allergy) or absolute contraindication to iodine contrast;
• • 14. Any terminal illness with life expectancy less than 6 months;
• • 15. Participating in other clinical trials;
• • 16. Other conditions deemed unsuitable for the study by the investigator, such as inability to comprehend or comply with study procedures or follow-up due to mental illness, cognitive or emotional disorder.