acute ischemic stroke
Conditions
Interventions
Experimental Group:140 mg of evolocumab by subcutaneous injection every 2 weeks
continuous administration for 26 weeks, of which a total of 13 doses of evolocumab
control group:Atorvastatin 40mg/day or rosuvastatin 20mg/day for 26 weeks
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females Aged >=18 years; 2. Meets all the following criteria at the qualifying cerebral angiogram: 1) Angiographic stenosis of the internal carotid artery (from the origin to the C1 segment) or the vertebral artery (from the origin of the vertebral artery to the V1 segment) is 30%-69%; 2)Target vessel for imaging has not undergone or is intended to undergo revascularization and must be OCTA-ready through the OCT imaging catheter. 3. Fasting LDL-C >= 1.8mmol/L; 4. Great compliance, agreed to sign informed consent and accept follow-up.
Exclusion criteria
Exclusion criteria: 1.Intolerant to both atorvastatin and rosuvastatin; 2. History of major surgery or endovascular treatment within 3 months prior to the screening period; 3. Arterial stenosis or occlusion not caused by atherosclerosis, such as arterial dissection, moya-moya disease, vasculitis, radiation vascular disease, or fibromuscular dysplasia; 4. Abnormal liver function (ALT > 3 times the upper limit of normal); 5. Renal dysfunction (glomerular filtration rate (eGFR) <45 mL/min/1.73m2 at screening); 6. Thrombocytopenia (PLT<100G/L); 7. The expected survival time is not more than 6 months; 8. Other known serious life-threatening disease (such as hematologic disease, malignancy), unstable vital signs or need for continuous monitoring, or moribund state during screening; 9. Patients have been included in other studies that conflict with this study; 10. Known sensitivity to any of the products or components to be administered during dosing; 11. Pregnant, breastfeeding or planning pregnancy, and other conditions that the investigator considers the patient unsuitable for enrollment; 12. Other conditions that the investigator considered inappropriate for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial plaque minimum fibrous cap thickness measured by OCT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Lipid arcs measured by OCT;Minimum lumen area (MLA) measured by OCT;Lumen stenosis measured by OCT;OCT-measured number of microchannels and presence and extension of macrophages, calcium accumulation;Arterial plaque volume measured by OCT;Lipid necrotic core of arterial plaque measured by OCT;LDL-C;FFR;Arterial minimum fibrous cap thickness measured by arterial three-dimensional ultrasound;Arterial plaque volume measured by three-dimensional ultrasound of the carotid artery;Lipid necrotic core measured by three-dimensional ultrasound of the carotid artery;Arterial minimum fibrous cap thickness measured by high-resolution magnetic resonance imaging;Arterial plaque volume measured by high-resolution magnetic resonance imaging;Arterial lipid necrosis core measured by high-resolution magnetic resonance; | — |
Countries
China
Contacts
Public ContactBo Hu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed