Tirofiban+Oral Dual Antiplatelet Therapy: Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 47.5 hours; sequential Oral Dual Antiplatelet Therapy (Aspirin 100mg qd; Clopidogrel 75mg qd)
Oral Dual Antiplatelet Therapy: Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)
Study summary
This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of excellent functional outcomes (mRS 0-1) — 90 days The mRS is an ordinal, graded interval scale that assigns patients among 7 global disability levels, which ranging from 0 (no symptom) to 5 (severe disability) and 6 (death)
Trial sites (18)
Facility
City
Region
Status
Suzhou Municipal Hospital of Anhui Province
Suzhou
Anhui
Recruiting
Second Hospital of Hebei Medical University
Shijiazhuang
Hebei
Recruiting
Taikang Xian People's Hospital
Zhoukou
Henan
Recruiting
WuYuan County People's Hospital
Bayan Nur
Inner Mongolia
Recruiting
Huai'an First People's Hospital
Huai'an
Jiangsu
Recruiting
Jiangsu Province (Suqian) Hospital
Suqian
Jiangsu
Recruiting
Second Affiliated Hospital of Soochow University
Suzhou
Jiangsu
Recruiting
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
Suzhou
Jiangsu
Recruiting
Changshu No.1 People's Hospital
Suzhou
Jiangsu
Recruiting
First People's Hospital of Kunshan
Suzhou
Jiangsu
Recruiting
Suzhou Ninth People's Hospital
Suzhou
Jiangsu
Recruiting
Suzhou Xiangcheng People's Hospital
Suzhou
Jiangsu
Recruiting
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou
Jiangsu
Recruiting
Zhangjiagang Hospital of Traditional Chinese Medicine
Suzhou
Jiangsu
Recruiting
Taixing Second People's Hospital
Taizhou
Jiangsu
Recruiting
Nuclear Industry 417 Hospital
Xi'an
Shaanxi
Recruiting
First People's Hospital of Xianyang
Xianyang
Shaanxi
Recruiting
Second Hospital of Tianjin Medical University
Tianjin
China
Recruiting
More Second Affiliated Hospital of Soochow University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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