Acute ischemic stroke
Conditions
Interventions
Intervention group:Thrombectomy Alone + Evolocumab
Thrombectomy Alone: Mechanical thrombectomy was performed in accordance with guidelines (which may include necessary angioplasty/stent placement). P
Control group:Simple thrombectomy treatment: Complete mechanical thrombectomy in accordance with the guidelines (including necessary angioplasty/stent implantation, if necessary).
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 85 years, inclusive, regardless of gender; 2. Clinically diagnosed with acute ischemic stroke due to anterior circulation large vessel occlusion, confirmed by CTA and/or DSA that the occluded culprit vessel is the intracranial segment of the internal carotid artery (ICA) or the M1 segment of the middle cerebral artery (MCA); 3. The time from onset of the disease to puncture was within 24 hours. Mechanical thrombectomy (MT) treatment was received (including direct thrombectomy and bridging thrombectomy with intravenous thrombolysis), and the degree of vascular recanalization reached mTICI grade 2b or 3 after the operation. The surgical indications and time window followed the current guidelines and imaging criteria of key randomized controlled trials (RCTs), as defined below: (1) Early Window (0–6 h): Meets conventional endovascular therapy (EVT) criteria (anterior circulation LVO, baseline NIHSS >=6, ASPECTS >=6, or institutional standards), with the final decision for MT made by the interventional team; (2) Late Window (6–24 h): Must meet the imaging selection criteria of either the DAWN or DEFUSE-3 trial (based on CTP-RAPID or MRI-DWI/perfusion): 1) DAWN Criteria (6–24 h) (meet one): Age >=80 years: NIHSS >=10 and core infarct volume =10 and core infarct volume =20 and core infarct volume 31–51 mL; 2) DEFUSE-3 Criteria (6–16 h) (meet all): Core infarct volume =1.8, mismatch volume >=15 mL, and Tmax >6 s volume >15 mL; The determination of the culprit vessel and etiology as intracranial atherosclerosis (ICAD-LAA) should follow guideline standards (DSA/CTA evidence + exclusion of cardioembolic sources); 4. The stroke etiology is classified as intracranial atherosclerotic disease (ICAD-LAA), defined by imaging evidence of atherosclerotic stenosis/plaque in the culprit vessel, supported by relevant atherosclerotic risk factors (e.g., other intracranial/extracranial arterial stenosis, hypertension, diabetes mellitus); 5. Baseline National Institutes of Health Stroke Scale (NIHSS) score >=6; 6. Good pre-stroke functional status, with a pre-morbid modified Rankin Scale (mRS) score <=2 (no severe disability); 7. Ability to receive the study drug injection as required by the protocol; 8. The patient or their legally authorized representative provides written informed consent, demonstrates understanding of the study content, and agrees to comply with follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Non-atherosclerotic lesions (e.g., arterial dissection, Moyamoya disease, vasculitis, or undetermined embolic source); 2. Intracranial hemorrhage present at admission with imaging evidence of significant hemorrhagic tendency, making continued participation in the study inappropriate; 3. Stroke etiology is cardioembolic (e.g., history of atrial fibrillation, valvular heart disease); 4. Known hypersensitivity to evolocumab or any of its excipients; 5. Severe hepatic or renal dysfunction: baseline ALT or AST >=3^x ULN, or significantly reduced creatinine clearance (eGFR <30 mL/min/1.73m^2); 6. Active severe infection, autoimmune disease, or other serious comorbidities significantly affecting prognosis (e.g., active malignancy, end-stage disease); 7. Patients who received PCSK9 inhibitor therapy within the prior 4 weeks (to avoid interference due to altered tolerability or mechanism of action); 8. Pregnant or lactating women; 9. Expected survival <90 days or presence of other serious illnesses; 10. Currently participating in another interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Neurological Deterioration (END);Safety Endpoints: 1. Symptomatic intracranial hemorrhage (sICH, using Heidelberg Bleeding Classification Criteria); 2. All-cause mortality (up to Day 90); 3. Other adverse events.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness: 1. 90-day functional outcome (rate of mRS 0-2 scores ); 2. Stroke recurrence rate;Mechanism Exploration: 1. Dynamic changes in serum levels of PCSK9, hsCRP, IL-6, S100ß, and NSE from baseline to 36 h and 72 h; 2. Correlation between the changes in the above biomarkers and END.;24-hour ineffective recanalization rate after intervention; | — |
Countries
China
Contacts
Public ContactFeng Yu
Xuzhou Medical College Affiliated Hospital
Outcome results
None listed