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Clinical Trials in China / NCT07095790
Recruiting Phase 4

Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

NCT07095790 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Soochow University
Phase
Phase 4
Started
2025-08-30
Last updated
2025-07-31

Condition(s) studied

Mild Stroke

Investigational drug(s) / intervention(s)

Tirofiban+Oral Dual Antiplatelet TherapyOral Dual Antiplatelet Therapy

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)

Trial sites (18)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07095790 on ClinicalTrials.gov ↗ ← All trials in China