Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07242599

PHASE3

Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Sponsor: Beijing Tiantan Hospital

View on ClinicalTrials.gov

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).

Official title: A Multicenter, Randomized, Open-label, Parallel-controlled, Event-driven, Blinded-endpoint Trial Evaluating the Efficacy and Safety of Ongericimab Injection in High-risk Stroke Patients With Intracranial or Extracranial Atherosclerotic Stenosis.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4810

Start Date

2026-05

Completion Date

2029-04-01

Last Updated

2026-04-08

Healthy Volunteers

Conditions

Ischemic Cerebral Infarction

Interventions

COMBINATION_PRODUCT

High target group

Standardized lipid-lowering therapy according to the Chinese Stroke Association Guidelines for Clinical Management of Cerebrovascular Diseases to achieve an LDL-C target below 70 mg/dL (1.8 mmol/L)

COMBINATION_PRODUCT

Low target group

Ongericimab subcutaneous injection once every two weeks (150mg) or every four weeks(300mg) combined with standardized lipid-lowering therapy to achieve an LDL-C target below 55 mg/dL (1.4 mmol/L)

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, 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); * Active liver disease or dysfunction (AST/ALT \>3×ULN within 30 days pre-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 the study by the investigator.

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China