Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

Launched by SECOND AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medicine called tirofiban, given through a vein within 48 hours after a mild stroke, can help patients recover better than the usual treatment with two standard blood-thinning medicines taken by mouth. Tirofiban is given as a continuous drip for 48 hours, followed by the usual medicines, to see if this approach improves patients’ chances of having little to no disability after their stroke.

Adults between 18 and 80 years old who have had a mild stroke—not caused by heart problems—and can start treatment within 48 hours of symptoms beginning may be eligible. People who join will receive either the new treatment (tirofiban plus standard medicines) or the usual treatment alone, and their recovery will be closely monitored. Certain conditions, like recent bleeding in the brain, severe kidney problems, or recent major surgery, may prevent someone from joining. This study is currently looking for participants, and if you or a loved one fits these criteria, it could be an option to discuss with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-80 years old.
• • 2. Acute mild non-cardioembolic stroke.
• • 3. NIHSS score ≤5.
• • 4. Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.
• • 5. The investigational drug can be administered within 48 hours of symptom onset.
• • 6. Signed informed consent by the patient or legally authorized representative.
• Exclusion Criteria:
• • 1. Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
• • 2. Intracranial hemorrhage confirmed by imaging.
• • 3. Pre-stroke modified Rankin Scale (mRS) score ≥2.
• • 4. Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \<30%.
• • 5. History of primary intracerebral hemorrhage.
• • 6. History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
• • 7. Untreated or inadequately treated intracranial aneurysm or vascular malformation.
• • 8. Major systemic bleeding within 30 days.
• • 9. Active bleeding, including laboratory evidence of coagulopathy (platelet count \<100 × 10⁹/L, activated partial thromboplastin time \>50 seconds, or international normalized ratio \>1.7), or treatment with direct oral anticoagulants within the preceding 48 hours.
• • 10. Major surgery within 14 days.
• • 11. Persistently elevated blood pressure (systolic \>180 mmHg or diastolic \>110 mmHg) despite treatment.
• • 12. Baseline platelet count \<100 × 10⁹/L.
• • 13. Severe renal dysfunction (glomerular filtration rate \<30 mL/min or serum creatinine \>220 μmol/L \[2.5 mg/dL\]).
• • 14. Known allergy or contraindication to tirofiban or aspirin.
• • 15. Current pregnancy or lactation.
• • 16. Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
• • 17. Any terminal illness with life expectancy \<6 months.