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

This study is an investigator-initiated Phase 1b clinical trial employing an open-label, non-randomized, dose-escalation design. The primary objective is to evaluate the safety and tolerability of the investigational intervention and to determine the recommended dose for subsequent clinical studies.

Inclusion Criteria: * Age 18 to 80 years. * Imaging-confirmed anterior-circulation large-vessel occlusion involving the intracranial internal carotid artery, the middle cerebral artery M1 segment, or the proximal M2 segment or a dominant M2 branch. A dominant M2 branch was defined as an M2 branch supplying ≥50% of the middle cerebral artery territory. * Eligible for and planned to undergo endovascular treatment (EVT) within 24 hours according to current clinical practice. * National Institutes of Health Stroke Scale (NIHSS) score ≥6 at baseline. * Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on baseline noncontrast CT. * Pre-stroke modified Rankin Scale (mRS) score of 0 to 1. * Provision of written informed consent by the participant or the participant's legally authorized representative. Exclusion Criteria: * Evidence of intracranial hemorrhagic disease on head CT, including hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, or subarachnoid hemorrhage. * History of congenital or acquired bleeding disorders, coagulation factor deficiency, thrombocytopenic disorders, or other clinically significant hemorrhagic conditions. * Vascular anatomy expected to preclude successful endovascular treatment because of excessive tortuosity or other technical reasons. * Known allergy to iodinated contrast agents. * Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 90 days after enrollment. * Known hypersensitivity to anisodine hydrobromide or a history of severe intolerance after prior exposure. * Presence of clinical conditions that may be worsened by anticholinergic drugs, including but not limited to angle-closure glaucoma, urinary retention or benign prostatic hyperplasia with dysuria, or paralytic ileus. * Severe arrhythmia or hemodynamic instability, including but not limited to tachyarrhythmia requiring cardioversion, recurrent syncope due to arrhythmia, vasopressor-dependent hypotension, or persistent hypotension. * Severe psychiatric disorder, dementia, or impaired consciousness that would preclude informed consent or protocol-required follow-up. * Malignant tumor or other severe systemic disease with an expected survival of less than 90 days. * Participation in another interventional clinical study within 30 days before enrollment, or current participation in another interventional clinical study. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.