Cerebrovascular disease
Conditions
Interventions
High target group:Receiving standardized lipid-lowering treatment to achieve an LDL-C reduction target below 70 mg/dL (1.8 mmol/L)
Low target group:Receiving Angorexi injection every 2 weeks (150 mg) or every 4 weeks (300 mg) in combination with standardized lipid-lowering therapy to achieve an LDL-C reduction target of below 55
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Obtain informed consent; 2. Age >= 18 years; 3. Patients with ischemic stroke within 3 months of onset; 4. NIHSS score = 50% confirmed by carotid ultrasound or head and neck vascular imaging, and related to the current symptoms or infarct location; 6. LDL-C must be >= 70 mg/dL (1.8 mmol/L) at screening.
Exclusion criteria
Exclusion criteria: 1.History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion); 2.Hemorrhage or other pathological neurological conditions on baseline brain CT/MRI (e.g., vascular malformations, tumors, abscesses, or common non-ischemic brain diseases like multiple sclerosis); 3.Presence of isolated sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness or vertigo, but no evidence of recent infarction on baseline head CT or MRI; 4.Unable to complete the assessment of intracranial and extracranial arterial stenosis before randomization; 5.mRS score >2 before onset (based on assessment of medical history); 6.Stroke caused by angioplasty/vascular surgery; 7.Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc. 8.Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization; 9.Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg); 10.Hypothyroidism diagnosed within 1 month before randomization. 11.Severe renal impairment (eGFR 3×ULN within 30 days pre-randomization); 13.NYHA Class III/IV heart failure within 1 year prior to randomization; 14.Life-limiting non-cardiovascular diseases (life expectancy <1 years); 15.Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer); 16.Known hypersensitivity to monoclonal antibody therapies; 17.PCSK9 inhibitor use within 3 months before randomization. 18.Participation in other drug/device trials within 30 days; 19.Women of childbearing potential without contraception, pregnancy, or lactation; 20.Inability to understand or comply with the study due to mental illness, cognitive, or emotional disorders, or other reasons deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes.;Any serious adverse events that occurred during the clinical trial period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial infarction;Vascular death;Any adverse events that occurred during the clinical trial period;Absolute change and percentage change in LDL-C level;The severity of the new stroke (severity is classified into an ordered 6-level scale based on mRS: fatal stroke [mRS 6] / severe non-fatal stroke [mRS 4 or 5] / moderate stroke [mRS 2 or 3] / mild str;New ischemic stroke;After 1 year of randomization, the mRS score was 0-1 or showed an improvement of =1 point compared to the baseline;Any new onset stroke (ischemic stroke or hemorrhagic stroke) or TIA; | — |
Countries
China
Contacts
Public ContactYongjun Wang
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed