Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke

Recruiting now · Phase 4

Conditions studied: Mild Stroke

In brief

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.

Key facts

Study ID

NCT07095790

Run by

Second Affiliated Hospital of Soochow University

People needed

580

Starts

2025-08-30

Expected to finish

2027-05-31

Last updated by the study team

2025-07-31

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18-80 years old.
• Acute mild non-cardioembolic stroke.
• NIHSS score ≤5.
• 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.
• The investigational drug can be administered within 48 hours of symptom onset.
• Signed informed consent by the patient or legally authorized representative.

You may not qualify if…

• Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)
• Intracranial hemorrhage confirmed by imaging.
• Pre-stroke modified Rankin Scale (mRS) score ≥2.
• 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%.
• History of primary intracerebral hemorrhage.
• History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).
• Untreated or inadequately treated intracranial aneurysm or vascular malformation.
• Major systemic bleeding within 30 days.
• 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.
• Major surgery within 14 days.
• Persistently elevated blood pressure (systolic >180 mmHg or diastolic >110 mmHg) despite treatment.
• Baseline platelet count <100 × 10⁹/L.
• Severe renal dysfunction (glomerular filtration rate <30 mL/min or serum creatinine >220 μmol/L [2.5 mg/dL]).
• Known allergy or contraindication to tirofiban or aspirin.
• Current pregnancy or lactation.
• Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).
• Any terminal illness with life expectancy <6 months.

Where it is running

• Suzhou Municipal Hospital of Anhui Province — Suzhou, Anhui, China (enrolling)
• Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Taikang Xian People's Hospital — Zhoukou, Henan, China (enrolling)
• WuYuan County People's Hospital — Bayan Nur, Inner Mongolia, China (enrolling)
• Huai'an First People's Hospital — Huai'an, Jiangsu, China (enrolling)
• Jiangsu Province (Suqian) Hospital — Suqian, Jiangsu, China (enrolling)
• Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (enrolling)
• Affiliated Jiangsu Shengze Hospital of Nanjing Medical University — Suzhou, Jiangsu, China (enrolling)
• Changshu No.1 People's Hospital — Suzhou, Jiangsu, China (enrolling)
• First People's Hospital of Kunshan — Suzhou, Jiangsu, China (enrolling)
• Suzhou Ninth People's Hospital — Suzhou, Jiangsu, China (enrolling)
• Suzhou Xiangcheng People's Hospital — Suzhou, Jiangsu, China (enrolling)
• Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine — Suzhou, Jiangsu, China (enrolling)
• Zhangjiagang Hospital of Traditional Chinese Medicine — Suzhou, Jiangsu, China (enrolling)
• Taixing Second People's Hospital — Taizhou, Jiangsu, China (enrolling)
• Nuclear Industry 417 Hospital — Xi'an, Shaanxi, China (enrolling)
• First People's Hospital of Xianyang — Xianyang, Shaanxi, China (enrolling)
• Second Hospital of Tianjin Medical University — Tianjin, China (enrolling)

Full record on ClinicalTrials.gov

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