Acute ischemic stroke (AIS) accounts for about 60-70% of all strokes, consisting of the major disease burden of stroke.
Conditions
Interventions
PCSK9 inhibitors group:PCSK9 inhibitors (enomumab, aleximumab)
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years. 2. Diagnosis of acute ischemic stroke (AIS) according to the 2018 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke. 3. Severe stenosis or occlusion of anterior circulation large vessels confirmed by DSA/MRA/CTA. 4. Eligible for endovascular therapy (EVT) per the 2022 Chinese Guidelines for Endovascular Treatment of Acute Ischemic Stroke, with successful recanalization after emergency EVT. 5. Fasting LDL-C >1.8 mmol/L or non-HDL cholesterol >2.6 mmol/L. 6. Signed informed consent by the patient or legal guardian.
Exclusion criteria
Exclusion criteria: 1. Non-atherosclerotic causes of stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, or iatrogenic/surgical causes). 2. History of intracranial hemorrhage or systemic bleeding within 3 months. 3. Immediate post-procedural hemorrhagic transformation (PH1/PH2 per ECASS classification). 4. Severe hepatic impairment, defined as: ALT >3× upper limit of normal (ULN), INR >1.2, Hepatic encephalopathy, or Prior drug-induced liver injury. 5. Use of PCSK9 inhibitors within 6 months prior to enrollment. 6. Pre-stroke mRS score >=2. 7. Terminal illness (e.g., advanced malignancy, end-stage renal disease) with life expectancy <3 months. 8. Pregnancy or lactation. 9. Concurrent neurological disorders that may confound functional outcome assessments. 10. Known allergy or intolerance to PCSK9 inhibitors or statins. 11. Participation in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a modified Rankin Scale (mRS) score <= 2 at 90 days post-onset.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Magnitude of low-density lipoprotein (LDL-C) reduction;Incidence of malignant cerebral edema within 48-72 hours post-onset;Proportion of patients with early neurological deterioration;Magnitude of midline shift measured at 72-96 hours post-onset;Incidence of adverse events;incidence of symptomatic hemorrhagic transformation;Incidence of acute liver injury;Incidence of early artery reocclusion or early recurrent stroke;90-day mortality;Change in cerebrospinal fluid (CSF) parameters from baseline at 72 hours post-onset;Proportion of patients with early neurological improvement;Distribution of 90-day mRS scores; | — |
Countries
China
Contacts
Public ContactWu Yongming
Southern Medical University Southern Hospital
Outcome results
None listed