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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
4,398
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)
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)
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
The major cardiovascular events
The composite primary end point of major cardiovascular events includes ischemic stroke, myocardial infarction, death from cardiovascular causes.
Time frame: A median of 2 years follow-up
New ischemic stroke
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.
Time frame: A median follow-up of 2 years
Myocardial infarction
Time frame: A median of 2 year follow-up
Vascular death
Time frame: A median of 2 years follow-up
Poor functional prognosis (mRS score > 1) at 1 year
Time frame: A median of 2 years follow-up
Severity of new stroke
Time frame: A median of 2 years follow-up
Absolute and percent changes in LDL-C levels
Time frame: A median of 2 years follow-up
Absolute and percent changes in Lp(a) levels.
Time frame: A median of 2 years follow-up
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Treatment-emergent serious adverse events (SAEs) and adverse events (AEs)
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.
Time frame: A median of 2 years follow-up