A Phase 2 interventional study of Anisodine Hydrobromide and Anisodine Hydrobromide Placebo in Acute Ischemic Stroke, sponsored by Capital Medical University. Recruiting at 11 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Capital Medical University · Phase 2, Interventional, and Treatment
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.
Eligible participants will be randomly assigned to receive anisodine hydrobromide or matching placebo in addition to standard care, with efficacy and safety assessed during follow-up.
Exclusion Criteria:
Participants will receive anisodine hydrobromide combined with endovascular thrombectomy.
Drug: Anisodine Hydrobromide
Participants will receive placebo combined with endovascular thrombectomy.
Drug: Anisodine Hydrobromide Placebo
Anisodine 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.
An 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
Time frame: Day 8
NIHSS Score at 24 Hours
Time frame: 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.
Time frame: Day 8
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.
Time frame: Baseline to Day 8
mRS Score of 0-1 at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Time frame: 90 Days
mRS Score of 0-2 at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death
Time frame: 90 Days
Distribution of mRS scores at 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Time frame: 90 Days
EQ-5D-5L at 90 Days
The EQ-5D-5L index score ranges from -0.391 to 1.000 using the Chinese value set, with higher scores indicating better health-related quality of life.
Time frame: 90 Days
Barthel Index Score of 95-100 at 90 Days
The Barthel Index ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Time frame: 90 Days
Neurological Deterioration Within 24 Hours
an increase of ≥4 points in the NIHSS score from baseline
Time frame: Within 24 hours
Symptomatic Intracranial Hemorrhage Within 8 Days
Time frame: Within 8 Days
All Cause Mortality at 90 Days
Time frame: Within 90 days
Intracranial Hemorrhage Within 8 Days
Time frame: Within 8 Days
Plan to share: No
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Capital Medical University