Acute branch Atheromatous Disease(BAD)
Conditions
Interventions
Trial Group:Tirofiban hydrochloride sodium chloride injection: bolus dose of 0.4 ug/kg/min for 30 min, followed by maintenance infusion at 0.1 ug/kg/min for 48 hours
dual antiplatelet therapy with aspirin 100 mg/d and clopidogrel 75 mg/d (loading dose of 300 mg) initiated immediately after randomization
overlap with dual antiplatelet therapy started 4-6 hours before tirofiban discontinuation, lasting 21 days, then switched to single oral antiplatelet therapy.
Control Group:Dual antiplatelet therapy (DAPT): aspirin 100 mg/d plus clopidogrel 75 mg/d (loading dose of 300 mg), for 21 days, followed by single oral antiplatelet therapy (aspirin or clopidogrel).
Sponsors
Chengdu Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years; 2. Acute ischemic stroke confirmed by head CT, MRI, or DWI; 3. Time from onset to randomization 15 mm, involving >=3 slices, and stenosis of the responsible vessel 50%) or occlusion of the main branch artery; (3) Posterior type infarction of the lenticulostriate artery: multiple infarcts in the penetrating artery distribution area; 6. Subjects provide informed consent, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. High-risk factors for cardioembolism: atrial fibrillation, atrial flutter, acute myocardial infarction, severe valvular heart disease, dilated cardiomyopathy, infective endocarditis; 2. Received or planned to receive endovascular therapy/thrombolysis after onset; 3. Long-term use of dual antiplatelet therapy or currently taking dual antiplatelet drugs within 2 weeks prior to randomization; 4. Stroke of other definite etiology: e.g., moyamoya disease, arterial dissection, vasculitis, etc.; 5. Pre-stroke modified Rankin Scale (mRS) score >=1; 6. Stenosis >=50% of the ipsilateral extracranial/intracranial large artery supplying the infarct territory; 7. Imaging suggests high bleeding risk: e.g., severe white matter lesions (Blennow score 3 or modified Fazekas score 3), multiple lacunar infarcts, or lacunar state; 8. Bleeding tendency or coagulation abnormality: platelet count 15 s, APTT >40 s, INR >1.5, use of novel oral anticoagulants, hematologic disorders, etc.; 9. Abnormal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal; 10. Renal insufficiency: creatinine clearance 10 mm in diameter), or arteriovenous malformation; 15. Malignant hypertension; 16. Active or recent clinical bleeding event (e.g., gastrointestinal bleeding); 17. Life expectancy <=6 months; 18. Contraindications to MRI; 19. Women during menstruation, pregnant, or lactating; 20. Patients currently participating in other clinical studies; 21. Known allergy to tirofiban; 22. Planned intracranial, intraspinal, or other major surgery within the next 3 months; 23. Other conditions unsuitable for the study, such as psychiatric illness, cognitive or emotional disorders, or inability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with modified Rankin Scale score 0-1 at 90 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Early Neurological Deterioration (END) within 7 days after randomization (defined as an increase of >=2 points in NIHSS score within 1 week post-randomization);Proportion of patients with modified Rankin Scale score 0-2 at 90 days;Early Neurological Improvement (ENI) rate within 7 days;Change in NIHSS score within 7 days;Incidence of new vascular events within 90 days; | — |
Countries
China
Contacts
Public ContactWang Jian
Chengdu Second People's Hospital
Outcome results
None listed