Ischemic Stroke
Conditions
Interventions
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; 2. Acute ischemic stroke, receiving intravenous thrombolysis within 4.5 hours of onset; 3. Baseline NIHSS score 5-15, with at least one limb NIHSS motor item score >= 2; 4. Pre-stroke mRS 0-1; 5. Non-large vessel occlusion (CTA/MRA excludes internal carotid artery, M1 segment of middle cerebral artery, basilar artery occlusion); 6. Patient or their legally authorized representative provides informed consent.
Exclusion criteria
Exclusion criteria: 1. Planned endovascular treatment; 2. Intracranial hemorrhage or hemorrhagic transformation; 3. Received PCSK9 monoclonal antibody therapy within 1 month before enrollment, or PCSK9 siRNA therapy within 6 months before enrollment; 4. Patients allergic to PCSK9 inhibitors; 5. Severe liver dysfunction (ALT or AST >3 times the upper limit of normal); 6. Severe renal dysfunction (eGFR <30 ml/min/1.73m^2); 7. Pregnant or breastfeeding women; 8. Expected life expectancy <6 months; 9. Currently participating in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS scores of 0–2 (functional independence) at 90 days.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with mRS scores of 0–1 (favorable functional outcome) at 90 days.;Recurrent stroke (ischemic or hemorrhagic) at 90 days;Change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to Day 7, Day 30, and Day 90;Infarct volume assessed by MRI or CT at 24 to 72 hours;Change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to Day 5-7 or discharge (whichever occurs first);Rate of LDL-C target achievement at 90 days;All-cause mortality at 90 days;Incidence of symptomatic intracranial hemorrhage (sICH) within 24 to 48 hours;Distribution of mRS scores at 90 days; | — |
Countries
China
Contacts
Public ContactBo Hu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed