Anisodine Hydrobromide for Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy (HEAL-2)

Efficacy and Safety of Anisodine Hydrobromide in Patients With Ischemic Stroke Undergoing Endovascular 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.

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