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.
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Eligibility Criteria
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 s…
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.
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