Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

4398 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2029-04-01

Brief Summary

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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).

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Detailed Description

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Conditions

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Ischemic Cerebral Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group (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).

Group Type ACTIVE_COMPARATOR

High target group

Intervention Type COMBINATION_PRODUCT

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)

Intervention group (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)

Group Type EXPERIMENTAL

Low target group

Intervention Type COMBINATION_PRODUCT

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)

Interventions

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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)

Intervention Type 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)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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);
* Active phase of infection (including respiratory tract infection, urinary tract infection, or gastroenteritis), or currently using or planning to use oral or intravenous anti-infective treatment due to infection;
* Known hypersensitivity to monoclonal antibody therapies;
* PCSK9 inhibitor use within 3 months before randomization.
* Participation in other drug/device trials within 30 days;
* History of severe drug or alcohol abuse within the past year.
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No