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.
NCT Number: NCT07800572
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Phase 2
Anyang People's Hospital, Anyang, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 8
Time frame: 24 hours
Time frame: Day 8
The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment and a worse outcome.
Time frame: 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: 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Time frame: 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death
Time frame: 90 Days
The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Time frame: 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
The Barthel Index ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living.
Time frame: Within 24 hours
an increase of ≥4 points in the NIHSS score from baseline
Time frame: Within 8 Days
Time frame: Within 90 days
Time frame: Within 8 Days
Interested in participating?
Request InfoCapital Medical University
Other
Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular Treatment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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