RECRUITINGPhase 4INTERVENTIONAL
Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke
Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form by the patient or legally authorized representative.
Who Should NOT Join This Trial:
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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
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)
DRUG
Oral Dual Antiplatelet Therapy
Aspirin 100mg qd; Clopidogrel 75mg qd (after first dose of 300mg)
Locations (18)
Suzhou Municipal Hospital of Anhui Province
Suzhou, Anhui, China
Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Taikang Xian People's Hospital
Zhoukou, Henan, China
WuYuan County People's Hospital
Bayan Nur, Inner Mongolia, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Jiangsu Province (Suqian) Hospital
Suqian, Jiangsu, China
Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Jiangsu Shengze Hospital of Nanjing Medical University
Suzhou, Jiangsu, China
Changshu No.1 People's Hospital
Suzhou, Jiangsu, China
First People's Hospital of Kunshan
Suzhou, Jiangsu, China
Suzhou Ninth People's Hospital
Suzhou, Jiangsu, China
Suzhou Xiangcheng People's Hospital
Suzhou, Jiangsu, China
Taicang TCM Hospital Affiliated to Nanjing University of Chinese Medicine
Suzhou, Jiangsu, China
Zhangjiagang Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu, China
Taixing Second People's Hospital
Taizhou, Jiangsu, China
Nuclear Industry 417 Hospital
Xi'an, Shaanxi, China
First People's Hospital of Xianyang
Xianyang, Shaanxi, China
Second Hospital of Tianjin Medical University
Tianjin, China