Ischemic stroke
Conditions
Interventions
PCSK9i + statin combination therapy group:On the basis of the same statin therapy with or without ezetimibe, add subcutaneous injection of PCSK9 inhibitor evolocumab
Statin monotherapy group:Receive moderate-intensity statin monotherapy (atorvastatin calcium tablets 20mg qn or rosuvastatin calcium tablets 10mg qn)
if baseline LDL-C >= 2.6 mmol/L, combine with ezetimibe 10mg qd
Sponsors
Xi'an Jiaotong University Second Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–80 years, inclusive; 2. Meets the diagnostic criteria for symptomatic intracranial or extracranial atherosclerotic stenosis; 3. Admitted and underwent MRA examination within 7 days of symptom onset; 4. The degree of stenosis in the culprit vessel must be 50%–99%, as confirmed by Digital Subtraction Angiography (DSA). Computed Tomography Angiography (CTA) may serve as an alternative for confirming stenosis severity if DSA is unavailable. Eligible culprit vessels are: common carotid, internal carotid, middle cerebral, anterior cerebral, posterior cerebral, subclavian, vertebral, or basilar artery; 5. Fasting Low-Density Lipoprotein Cholesterol (LDL-C) >= 1.8 mmol/L measured at admission.
Exclusion criteria
Exclusion criteria: 1. Stroke etiology attributed to non-atherosclerotic causes, including but not limited to arterial dissection, Moyamoya disease, cardioembolism, vasculitis, coagulation disorders, or tumor embolism; 2. Unavailability of key laboratory tests (e.g., lipid profile) or imaging data, or poor data quality precluding reliable Signal Intensity Ratio (SIR) measurement; or culprit lesions located at arterial bifurcations/trifurcations or near perforating branches, which are unsuitable for SIR assessment; 3. History of ipsilateral intracranial or extracranial angioplasty or arterial thrombectomy within the past month; 4. Significant hepatic or renal dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 3 times the upper limit of normal, or an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2; 5. Prior use of PCSK9 inhibitors within 6 months before enrollment; 6. Comorbid severe systemic conditions, such as significant cardiovascular, hematologic, or respiratory diseases, active malignancy, or any other life-threatening illness; 7. Unwillingness or inability to complete the study follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early recurrent ischemic stroke,(ERIS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of stroke and functional recovery;Achievement of target lipid levels;Improvement of signal intensity ratio,(SIR);National Institutes of Health Stroke Scale (NIHSS) score; | — |
Countries
China
Contacts
Public ContactZhan Shuqin
Xi'an Jiaotong University Second Affiliated Hospital
Outcome results
None listed