Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Prior treatment

• Hypothyroidism diagnosed within 1 month before randomization.
• NYHA Class III/IV heart failure within 1 year prior to randomization;
• PCSK9 inhibitor use within 3 months before randomization.
• Participation in other drug/device trials within 30 days;

Other illness

• History of cerebral hemorrhage at any time (microhemorrhages present only on SWI are not an exclusion criterion)
• 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);
• Stroke caused by angioplasty/vascular surgery;
• Cardioembolic stroke caused by atrial fibrillation, artificial heart valves, endocarditis, mitral stenosis, sinus node dysfunction, etc.
• Uncontrolled hypertension (SBP \>180 mmHg or DBP \>110 mmHg);
• Malignancy within 10 years (excluding adequately treated basal cell carcinoma, cervical CIS, DCIS, or stage 1 prostate cancer);
• Known hypersensitivity to monoclonal antibody therapies;
• 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.

Lab values

• Most recent fasting triglycerides \>400 mg/dL (4.5 mmol/L) prior to randomization;
• Severe renal impairment (eGFR \<30 mL/min/1.73m²);
• Active liver disease or dysfunction (AST/ALT \>3×ULN within 30 days pre-randomization);

Age

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

Other

• 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;
• Unable to complete the assessment of intracranial and extracranial arterial stenosis before randomization
• mRS score≥2 before onset (based on assessment of medical history);
• Women of childbearing potential without contraception, pregnancy, or lactation;

• 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, and related to the symptoms of the current episode or the location of infarction；
• LDL-C ≥ 70 mg/dL (1.8 mmol/L) at screening.