Ongericimab Injection Reducing Recurrence of Ischemic Stroke
China4,810 participantsStarted 2026-04-22
Plain-language summary
The Oris trial aims to evaluate whether the use of Ongericimab injection in patients with atherosclerotic ischemic cerebrovascular disease within 3 months of onset can reduce the risk of recurrent major cardiovascular events by achieving lower lipid-lowering target values (LDL-C \< 1.4 mmol/L).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Obtaining informed consentï¼›
* 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.
Exclusion Criteria:
* 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);
* 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);
* 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)…