Ischemic Stroke
Conditions
Interventions
Super-Enhanced Treatment Group:Atorvastatin 40mg qd + Alirocumab 75mg q14h
Standard Treatment Group:Atorvastatin 40mg qd
Sponsors
The First People's Hospital of Foshan
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 30 - 80 years old. 2. Patients diagnosed with sICAS, meeting one of the following conditions: Transient ischemic attack (TIA) within 14 days. Mild to moderate ischemic stroke (mRS score = 3) within 14 days. 3. The responsible vessel for the above events is the cervical internal carotid artery (C6-C7 segment), middle cerebral artery M1 segment, or basilar artery, with 50%-99% stenosis confirmed by MRA or CTA. 4. Combined with clinical data, comprehensively assess that atherosclerosis is the cause of ICAS. 5. Patients can complete the treatment plan and follow-up as required, and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The etiology of ischemic events is embolic, including but not limited to rheumatic heart disease, atrial fibrillation/flutter, patent foramen ovale (PFO), cardiac myxoma, endocarditis, or other clear evidence of embolic causes. 2. The etiology of intracranial arterial stenosis is non-atherosclerotic, including but not limited to arterial dissection, moyamoya disease, vasculitis, neurosyphilis, vascular dysplasia, infectious diseases, hematological disorders, reversible cerebral vasoconstriction syndrome, vascular spasm, etc. 3. Received intravenous thrombolysis within the past 24 hours before enrollment. 4. Underwent emergency thrombectomy within the past 30 days before enrollment. 5. Received endovascular treatment of the head and neck vessels within the past 30 days before enrollment, or planned for related treatment (endovascular stent, balloon dilation, or carotid endarterectomy, etc.) within one year. 6. Experienced any intracranial hemorrhage within the past 180 days (including brain parenchyma, subarachnoid, subdural/extradural hemorrhage). 7. Experienced gastrointestinal bleeding or retinal hemorrhage within the past 180 days before enrollment. 8. Confirmed intracranial arteriovenous malformation or aneurysm by angiography. 9. Severe coagulation disorders. 10. Severe neurological impairment, defined as the inability of the patient to live independently. 11. Significant cognitive impairment that may affect the normal implementation of the treatment plan and follow-up. 12. Any malignant tumor or other serious illness leading to an expected survival of less than 3 years. 13. Patient is pregnant or planning to become pregnant. 14. Any of the following abnormalities in liver function, kidney function, or blood routine at the time of enrollment, specifically AST or ALT > 3 times the reference upper limit; blood creatinine > 265umol/L; creatinine clearance 5 times the reference upper limit. Use of PCSK9 inhibitors in the past 24 weeks. 15. Received immunosuppressive therapy (including glucocorticoids or immunosuppressants) for other diseases within the past 3 months. 16. Unable to tolerate high-intensity statin drugs. 17. Uncontrolled hypertension (SBP > 180mmHg or DBP > 110mmHg). 18. Uncontrolled diabetes (glycated hemoglobin > 8%). 19. Severe heart failure, NYHA class III or IV, or left ventricular ejection fraction <30% as shown by echocardiography. 20 Participating in other clinical studies or conditions deemed unsuitable for participation in this study by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative enhancement signal of the plaque; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in plaque volume in narrow vessel;Responsibility vessel stenosis rate;lumen area;wall area;LDL-C;LP(a);mRS score;NIHSS score; | — |
Countries
China
Contacts
Public ContactZefeng Tan
Department of Neurology, The First People's Hospital of Foshan, Foshan, Guangdong, China
Outcome results
None listed