Ischemic Cerebral Infarction
Conditions
Keywords
ischemic stroke, lipid lowering therapy, Ongericimab Injection, LDL-C target
Brief 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).
Interventions
COMBINATION_PRODUCTHigh 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_PRODUCTLow 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)
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The major cardiovascular events | A median of 2 years follow-up | The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New ischemic stroke | A median follow-up of 2 years | Ischemic stroke refers to acute focal cerebral or retinal infarction, excluding other non-ischemic causes, and meeting any of the following conditions: (1) clinical symptoms or imaging evidence of acute new focal neurological deficit lasting more than 24 hours; or (2) focal symptoms or signs lasting less than 24 hours, but with imaging evidence of new infarction; or (3) progression of pre-existing vascular ischemic stroke (i.e., NIHSS increase of ≥ 4 on the basis of the primary ischemic stroke, excluding hemorrhagic transformation after infarction or symptomatic intracranial hemorrhage) lasting more than 24 hours, with new ischemic changes on head MRI or CT. |
| Myocardial infarction | A median of 2 year follow-up | — |
| Vascular death | A median of 2 years follow-up | — |
| Poor functional prognosis (mRS score > 1) at 1 year | A median of 2 years follow-up | — |
| Severity of new stroke | A median of 2 years follow-up | — |
| Absolute and percent changes in LDL-C levels | A median of 2 years follow-up | — |
| Treatment-emergent serious adverse events (SAEs) and adverse events (AEs) | A median of 2 years follow-up | Treatment-emergent serious adverse events (SAEs) and adverse events (AEs) include cerebral hemorrhage, injection site infections, muscle-related adverse events, new-onset diabetes mellitus, and clinically significant laboratory abnormalities encompassing hepatic/renal function markers, creatine kinase (CK), fasting glucose, and glycated hemoglobin (HbA1c) during the double-blind treatment phase. |
Countries
China
Contacts
CONTACTYongjun Wang, MD
CONTACTLiye Dai, MD
PRINCIPAL_INVESTIGATORYongjun Wang
Beijing Tiantan Hospital
Outcome results
None listed