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
Qualifiers
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
Treatments tested in this trial
- High target group
- Low target group
Treatment groups
4,810 Participants
are divided into 2 treatment groupsLocations
199Fuyang People's Hospital236004, FuyangAnhui, China
The First Affiliated Hospital of Wannan Medical College241001, WuhuAnhui, China
The First Hospital of Fangshan District, Beijing102499, BeijingBeijing Municipality, China
Chongqing Sanbo Changan Hospital400023, ChongqingChongqing Municipality, China
Sponsors and collaborators
Beijing Tiantan Hospital
Lead sponsor
Source ClinicalTrials.gov