Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Inclusion Criteria:

• Obtaining informed consent；

• Age ≥18 years；

• Patients with ischemic stroke within 3 months( NIHSS<15 before randomization);

• Presence of ≥50% stenosis in major intracranial or extracranial arteries, andrelated to the symptoms of the current episode or the location of infarction；

• LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.

Exclusion Criteria:

• History of cerebral hemorrhage at any time (microhemorrhages present only on SWI arenot an exclusion criterion)

• Hemorrhage or other pathological neurological conditions on baseline brain CT/MRI (e.g., vascular malformations, tumors, abscesses, or common non-ischemic braindiseases like multiple sclerosis);

• Presence of isolated sensory symptoms (e.g., numbness), isolated visual changes, orisolated dizziness or vertigo, but no evidence of recent infarction on baseline headCT or MRI;

• Unable to complete the assessment of intracranial and extracranial arterial stenosisbefore randomization

• mRS score≥2 before onset (based on assessment of medical history);

• Stroke caused by angioplasty/vascular surgery;

• Cardioembolic stroke caused by atrial fibrillation, artificial heart valves,endocarditis, mitral stenosis, sinus node dysfunction, etc.

• Most recent fasting triglycerides >400 mg/dL (4.5 mmol/L) prior to randomization;

• Uncontrolled hypertension (SBP >180 mmHg or DBP >110 mmHg);

• Hypothyroidism diagnosed within 1 month before randomization.

• Severe renal impairment (eGFR <30 mL/min/1.73m²);

• Active liver disease or dysfunction (AST/ALT >3×ULN within 30 dayspre-randomization);

• NYHA Class III/IV heart failure within 1 year prior to randomization;

• Life-limiting non-cardiovascular diseases (life expectancy <1 years);

• Malignancy within 10 years (excluding adequately treated basal cell carcinoma,cervical CIS, DCIS, or stage 1 prostate cancer);

• Known hypersensitivity to monoclonal antibody therapies;

• PCSK9 inhibitor use within 3 months before randomization.

• Participation in other drug/device trials within 30 days;

• Women of childbearing potential without contraception, pregnancy, or lactation;

• Inability to understand or comply with the study due to mental illness, cognitive,or emotional disorders, or other reasons deemed unsuitable for participation in thestudy by the investigator.