Acute branch Atherosclerosis disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years; 2. Acute ischemic stroke confirmed by head CT, MRI, or DWI; 3. Meets indications for intravenous thrombolysis, has no contraindications, and has received thrombolytic therapy; 4. NIHSS score =5 at 1 hour after completion of intravenous thrombolysis; 5. DWI sequence (slice thickness 5 mm) suggests a penetrating artery lesion and meets at least one of the following: ? Posterior limb of the internal capsule infarction (LSA territory): lesion diameter >15 mm, involving =3 slices, and stenosis of the responsible vessel 50%) or occlusion of the main branch artery³; ? Posterior-type lenticulostriate artery infarction: ? Multiple infarcts in a penetrating artery distribution; 6. The subject provides informed consent, voluntarily participates, and signs 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. Cortical or watershed infarction, or imaging suggesting high risk of hemorrhage: such as severe white matter disease Blennow score 3 or modified Fazekas score 3, multiple lacunar infarcts, or lacunar state; 3. Patients who should or have received arterial thrombolysis or mechanical thrombectomy; 4. Stroke with other clear etiology: such as moyamoya disease, arterial dissection, vasculitis, etc. 5. Pre-onset modified Rankin Scale mRS score = 1; 6. Stenosis = 50% in the ipsilateral extracranial or intracranial large arteries; 7. Bleeding tendency or coagulation abnormalities: platelet count 15s, APTT >40s, international normalized ratio INR >1.5, use of new oral anticoagulants, hematological diseases, etc. 8. Abnormal liver function: alanine aminotransferase ALT or aspartate aminotransferase AST > 3 times the upper limit of normal; 9. Renal insufficiency: creatinine clearance rate 10 mm or arteriovenous malformations; 14 Active or recent clinical bleeding events e.g., gastrointestinal bleeding; 15 Malignant hypertension; 16 Life expectancy = 6 months; 17 Contraindications to MRI; 18 Women during menstruation, pregnant, or breastfeeding; 19 Patients currently participating in other clinical studies; 20 Allergy to tirofiban; 21 Planned intracranial, intraspinal, or other major surgery within the next three months; 22 Long-term use or current use of dual antiplatelet therapy within 2 weeks prior to randomization; 23 Other conditions unsuitable for the study, such as psychiatric disorders, cognitive or emotional impairments, and inability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Outcome(s);mRS 0-1 at 90 days (%); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of END within 7 days after randomization;Proportion of Patients with 90?Day mRS Score 0–2 (%);Secondary Safety Endpoint(s);Change in NIHSS score within 7 days;Rate of early neurological improvement within 7 days;Occurrence of new vascular events within 90 days; | — |
Countries
China
Contacts
Chengdu Second People’s Hospital