Tirofiban plus dual antiplatelet therapy for mild 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 randomized interventional phase 4 comparison gives one group a 48‑hour intravenous tirofiban infusion started within 48 hours of symptom onset followed by sequential dual antiplatelet therapy, while the control group receives standard guideline-based oral dual antiplatelet therapy. Participants are adults aged 18–80 with acute mild non‑cardioembolic ischemic stroke (NIHSS ≤5) and no intracranial hemorrhage or major cardioembolic source. The main outcome is the proportion achieving an excellent functional outcome (modified Rankin Scale 0–1). Key exclusions include prior significant disability (pre‑stroke mRS ≥2), planned or received IV thrombolysis or bridging therapy, and confirmed cardioembolic conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• Suzhou Municipal Hospital of Anhui Province
  Suzhou, Anhui, China Recruiting
• Second Hospital of Hebei Medical University
  Shijiazhuang, Hebei, China Recruiting
• Taikang Xian People's Hospital
  Zhoukou, Henan, China Recruiting
• WuYuan County People's Hospital
  Bayan Nur, Inner Mongolia, China Recruiting
• Huai'an First People's Hospital
  Huai'an, Jiangsu, China Recruiting
• Jiangsu Province (Suqian) Hospital
  Suqian, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Jijun Shi, M.D — Second Affiliated Hospital of Soochow University
• Study coordinator: Jijun Shi, M.D
• Email: shijijun2008@126.com
• Phone: +86 512 67783689

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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.