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Ongericimab Injection Reducing Recurrence of Ischemic Stroke

Study acronym: ORIS
StatusNot Yet Recruiting
PhasePhase 3
Started2026-04-22
View on ClinicalTrials.gov ↗

Amendment history

2026-04-15
Study Status, Contacts/Locations v2
Trial sites expanded: 1 → 199 locations
Start date2026-05→2026-04-22
2026-04-02
Study Status, Study Design, Outcome Measures, Eligibility v1
Start date2025-12→2026-05
Enrollment target4398→4810
Eligibility criteria-275 characters
[...] 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; PCS [...] . 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, pregn [...]
Secondary endpoints8 to 7 entries
Absolute and percent changes in Lp(a) levels.
2025-11-17
Original filing
Beijing Tiantan Hospital
280 trials monitored
See 4 trials at risk
Stroke
3,268 trials monitored
See 122 trials at risk
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).
Trial Details
NCT Number NCT07242599
Lead Sponsor Beijing Tiantan Hospital
Conditions Ischemic Cerebral Infarction
Enrollment 4,810 participants
Start Date 2026-04-22
Primary Completion 2029-04-01 (estimated)
Study Completion 2029-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-16