Ongericimab Injection Reducing Recurrence of Ischemic Stroke
ConditionIschemic Cerebral Infarction
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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；
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
High target group
Combination productStandardized 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)
Low target group
Combination productOngericimab 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)
Treatment groups
4,810 Participants
are divided into 2 treatment groupsGroup A: Control group (High target group)Active comparator 1 intervention
Group B: Intervention group (Low target group)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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-upSecondary outcomes
1
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 years2
Myocardial infarction
Time frame
A median of 2 year follow-up3
Vascular death
Time frame
A median of 2 years follow-up4
Poor functional prognosis (mRS score > 1) at 1 year
Time frame
A median of 2 years follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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