acute ischemic stroke
Conditions
Interventions
Control group:Traditional lipid lowering therapy
Intervention group:PCSK9 inhibitors add-on therapy
Sponsors
Second Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 or over; 2. Meeting one of the following conditions: A recent transient ischemic attack (baseline ABCD2 >=4) within the past 3 days, or a recent acute ischemic stroke (mRS =70mg/dL (>=1.8mmol/L); 6. Patients or their legally authorized representatives understand the purpose and requirements of the present study, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Ipsilateral tandem extracranial artery stenosis (>=50%) or undefined responsible vessel; 2. Any known non-atherosclerotic intracranial arterial stenosis, including but not limited to intracranial arterial dissection, moyamoya disease, vasculitis, viral vasculopathy, neurosyphilis, intracranial infection, radiation vasculopathy, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, reversible vasoconstriction syndrome, postpartum vascular disease, vasospasm, suspected recanalization post vascular embolism; 3. Received intracranial or extracranial arterial endovascular treatment within 30 days before enrollment or plan to receive intracranial or extracranial arterial endovascular treatment (including angioplasty, endarterectomy or mechanical thrombectomy) within 30 days; 4. Intracranial hemorrhage, including cerebral parenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage or epidural hemorrhage, except for the intracranial microbleed detected by SWI; 5. Huge intracranial tumors, intracranial aneurysms or arteriovenous malformations before enrollment; 6. Presence of any of the following definite cardiogenic sources of embolism: mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, atrial fibrillation, left atrium spontaneous ultrasound development, ejection fraction 3 times the upper reference limit, creatinine clearance 265 µmol/L (3.0 mg/dL), creatine kinase >5 times the upper reference limit; 8. Active peptic ulcer, active bleeding tendency: corrected international normalized ratio > 1.5, bleeding time exceeding the upper reference limit for 1 minute, or increased bleeding risk due to heparin-related thrombocytopenia, major systemic bleeding within 30 days before enrollment; 9. Surgery within 30 days before or after enrollment, including cardiac surgery, open femoral surgery, aortic or carotid artery surgery; 10. Suffering from neurological or mental diseases which could affect neurological function scores or prognostic scores, having severe neurological deficits that prevent the patient from living independently, diagnosed with dementia or mental illness, which prevents the patient from completing the follow-up plan; 11. Life expectancy less than 30 days; 12. Women who plan to become pregnant, are pregnant or breastfeeding; 13. Received PCSK9 inhibitors within the past 24 weeks before enrollment; 14. Suffering from systemic immune diseases: systemic sclerosis, systemic lupus erythematosus, Sjogren's syndrome, Behcet's disease, mixed connective tissue disease, IgG4-related diseases; 15. Uncontrolled hypertension (systolic blood pressure > 185mmHg, or diastolic blood pressure > 110mmHg) during the screening period; 16. With relative/absolute contraindications of MRI (such as metals in the body, claustrophobia, contrast agent allergy, severe renal damage, ongoing epilepsy, hypotension, hyperthyroidism, asthma and other allergic respiratory diseases, or with allergic tendencies); 17. Participating in trials which conflict with the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence ischemic stroke/TIA within 30 days;All-cause mortality within 30 days; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day mRS 0-5;30-day composite vascular endpoints;30-day stroke-related death;30-day vascular related death;The incidence of adverse events within 30 days;Laboratory tests;30-day mRS 0-1;30-day mRS 0-2;30-day mRS 0-3;30-day mRS 0-4; | — |
Countries
China
Contacts
Public ContactJiang Yongjun
Wuxi people’s Hospital
Outcome results
None listed