Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Korábbi kezelés

• 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;

Más betegség

• 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.

Laborértékek

• 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);

Életkor

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

Egyéb

• 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.