This prospective multicenter cohort study aims to evaluate the effectiveness and safety of early PCSK9 inhibitor therapy in patients with large-artery atherosclerotic ischemic stroke. The study will compare early neurological improvement, lipid-lowering effect, 90-day functional outcome, recurrent cardio-cerebrovascular events, and safety outcomes between patients treated with evolocumab plus statin and those treated with statin alone.
Age 18-80 years.
Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria.
Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset.
NIHSS score 4-20 before treatment.
Hemorrhagic transformation or other intracranial hemorrhage (including hemorrhagic infarction, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma), except cerebral microbleeds detected only by SWI.
Prior intracranial or extracranial endovascular therapy before enrollment, planned acute endovascular therapy within 90 days, or planned surgery that may affect outcome assessment.
Severe cardiac insufficiency：NYHA class III or IV.
Severe hepatic dysfunction (ALT or AST >3 x upper limit of normal) or severe renal dysfunction (serum creatinine >2 mg/dL, eGFR <30 mL/min/1.73 m2, or requiring dialysis).
The study population consists of adult patients aged 18-80 years with acute ischemic stroke of the large-artery atherosclerotic (LAA) subtype, confirmed by clinical and imaging criteria within 72 hours of symptom onset. Eligible participants have baseline LDL-C ≥1.8 mmol/L, NIHSS score 4-20, and a pre-stroke modified Rankin Scale (mRS) score ≤1. Patients are consecutively enrolled from multiple tertiary hospitals in Heilongjiang Province during routine clinical care. All participants are candidates for statin therapy, with or without PCSK9 inhibitor (evolocumab), based on the actual clinical diagnosis and treatment plan. Key exclusions include intracranial hemorrhage, severe cardiac insufficiency, severe hepatic or renal dysfunction, major comorbidities affecting outcomes, and prior PCSK9 inhibitor use.
Cohort
Prospective
Not listed
Proportion of participants with favorable functional outcome at Day 90
Proportion of participants with modified Rankin Scale (mRS) score 0-2.
Ordinal distribution of mRS at Day 90
Distribution of mRS scores 0-6 at the 90-day follow-up assessment.
Incidence of early neurologic deterioration (END) and severe END
END: increase of ≥2 points in total NIHSS or ≥1 point in motor subscore within 7 days. Severe END: increase of ≥4 points in total NIHSS or ≥2 points in motor subscore within 7 days.
Change in NIHSS score from baseline
Change in NIHSS score from baseline to Day 7 (±2 days) or hospital discharge, whichever comes first.
Change in LDL-C from baseline
Change in fasting LDL-C concentration from baseline to the Day 30 follow-up assessment.
Adverse events
Incidence of adverse events from informed consent through the end of follow-up.
Serious adverse events
Incidence of serious adverse events from informed consent through the end of follow-up
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