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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
204
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.
Anyang People's Hospital
Anyang, China
NOT_YET_RECRUITINGXuanwu Hospital,Capital Medical University
Beijing, China
RECRUITINGAnji County People's Hospital
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
Chuanjie Wu, PhD/MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Huzhou, China
Jiuquan People's Hospital
Jiuquan, China
RECRUITINGLishui Central Hospital
Lishui, China
NOT_YET_RECRUITINGShangqiu First People's Hospitl
Shangqiu, China
RECRUITINGSuzhou Municipal Hospital of Anhui Province
Suzhou, China
RECRUITINGTaizhou Enze Medical Center (Group) Enze Hospital
Taizhou, China
RECRUITINGThe Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
RECRUITINGZhangpu County Hospital
Zhangzhou, China
RECRUITING...and 1 more locations
The Barthel Index ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Time frame: 90 Days