This phase 2, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of anisodine hydrobromide in patients with acute ischemic stroke undergoing endovascular thrombectomy.
Age 18-80 years
Anterior-circulation large-vessel occlusion involving the intracranial ICA, M1, or proximal/dominant M2
Eligible for endovascular treatment within 24 hours of last known well
Baseline NIHSS score ≥6
Intracranial hemorrhage on baseline imaging
Significant bleeding disorder or coagulopathy
Vascular anatomy unsuitable for EVT
Pregnancy, breastfeeding, or planned pregnancy within 90 days
Parallel
Anisodine Hydrobromide
DrugAnisodine hydrobromide, 2 mg per dose, diluted in 0.9% sodium chloride solution and administered by intravenous infusion twice daily for a total of 14 doses.
Anisodine Hydrobromide Placebo
DrugAn equivalent volume of 0.9% sodium chloride solution, administered by intravenous infusion twice daily for a total of 14 doses.
Cerebral Infarct Volume on Day 8
NIHSS Score at 24 Hours
NIHSS Score on Day 8
The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment and a worse outcome.
Change in NIHSS Score From Baseline to Day 8
The NIHSS ranges from 0 to 42. Change is calculated as the Day 8 score minus the baseline score.
mRS Score of 0-1 at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Neurological Deterioration Within 24 Hours
an increase of ≥4 points in the NIHSS score from baseline
Symptomatic Intracranial Hemorrhage Within 8 Days
All Cause Mortality at 90 Days
Intracranial Hemorrhage Within 8 Days
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