Anisodine hydrobromide added to standard care for acute ischemic stroke patients undergoing thrombectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, phase 2 randomized trial in adults with acute ischemic stroke due to large-vessel occlusion who are eligible for thrombectomy. Participants are randomly assigned to receive anisodine hydrobromide or a matching placebo in addition to standard care, and are followed to assess safety and effectiveness. The trial is double-blind and compares outcomes after treatment to determine if anisodine hydrobromide provides neuroprotection or other benefits. Eligible patients have specific imaging and clinical criteria and must provide consent or have a legally authorized representative. Sites include multiple hospitals in China and enrollments are designed to reflect routine endovascular practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* Baseline ASPECTS ≥6
* Pre-stroke mRS score 0-1
* Written informed consent provided by the participant or legally authorized representative

Exclusion Criteria:

* Intracranial hemorrhage on baseline imaging
* Significant bleeding disorder or coagulopathy
* Vascular anatomy unsuitable for EVT
* Pregnancy, breastfeeding, or planned pregnancy within 90 days
* Known hypersensitivity or severe intolerance to anisodine hydrobromide
* Contraindication to anticholinergic drugs
* Severe arrhythmia or hemodynamic instability
* Severe psychiatric disorder, dementia, or impaired consciousness precluding consent or follow-up
* Malignancy or other severe systemic disease with a life expectancy \<90 days
* Participation in another clinical trial within 30 days before enrollment or concurrently
* Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation

Where it's running

• Xuanwu Hospital，Capital Medical University
  Beijing, China Recruiting
• Anji County People's Hospital
  Huzhou, China Recruiting
• Jiuquan People's Hospital
  Jiuquan, China Recruiting
• Lishui Central Hospital
  Lishui, China Recruiting
• Shangqiu First People's Hospitl
  Shangqiu, China Recruiting
• Suzhou Municipal Hospital of Anhui Province
  Suzhou, China Recruiting

Study contacts

• Study coordinator: Xunming Ji, PhD/MD
• Email: jixm@ccmu.edu.cn
• Phone: 01083198962

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.