The study is being conducted to evaluate the efficacy, and safety of HRS8179 injection in preventing and treating severe cerebral edema after large area cerebral infarction in the cerebral hemisphere
Fully understand and voluntarily participate in this trial, and sign the informed consent form (the informed consent form can be signed voluntarily by the participant or their legal representative);
A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory;
National Institutes of Health Stroke Scale (NIHSS) ≥ 10 at screening;
A large hemispheric infarction defined as: lesion volume of 80 to 160 cm3 on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP).
Theparticipant is likely to withdraw the supportive treatment on the first day;
There is evidence indicating a concurrent infarction in the contralateral hemisphere sufficiently serious to affect functional outcome.
There are clinical signs of brain herniation; CT/MRI indicates a midline shift of >2 mm; CT/MRI indicates cerebral hemorrhage;
Parallel
HRS8179 injection
DrugHRS8179 injection; high dose
HRS8179 blank preparation.
DrugHRS8179 blank preparation.
Mortality rate at Day 90
The modified Rankin Scale (mRS) score at Day 90
The proportion of participants who achieved mRS score 0-4 at Day 90
Changes in midline shift from baseline to 72 hours
The proportion of participants who meet the indications for decompressive craniectomy by Day 14
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