The Androtriol Injection for the Treatment of Acute Ischemic Stroke

Inclusion criteria

• Age 18- 80 years, male or female；
• mRS score ≤1 prior to this onset;
• Planning to receive or have received intravascular recanalization therapy at our center within 24h of onset;
• To complete the first administration of the investigational medication within 24h of onset;
• NIHSS（National Institutes of Health Stroke Scale）score≥6 prior to intravascular recanalization;
• Informed consent.

Exclusion criteria

• Intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
• Severe disorders of consciousness: NIHSS 1a≥2 points;
• Large infarct core (ASPECTS <6, or>1/3 of MCA territory involved, as evidenced by CT or MRI);
• Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after medication control;
• History of severe kidney disease (such as dialysis), or eGFR <45 mL/min/1.73m²;
• History of severe liver disease, or ALT, AST levels more than 3 times of the upper limit of normal, or bilirubin more than 3 times of the upper limit of normal;
• Cardiovascular diseases, such as complete atrioventricular block, history of congestive heart failure (CHF), or heart function classification≥NYHA Class III;
• Critically ill patients with an expected lifespan≤90 days;
• History of epilepsy or epilepsy-like symptoms during stroke or severe psychiatric disorders, intellectual disability, or dementia;
• History of intracranial hemorrhage;
• Severe injury or surgery history within 3 months of onset;
• Have received>1 dose of neuroprotective drugs after this onset, such as edaravone, edaravone dexborneol injection, ginkgo lactone, ginkgo diterpene glucamine，etc;
• Allergy to the investigational drug (either the active ingredient androtriol or the excipient hydroxypropyl beta-cyclodextrin) or similar chemical structure drugs;
• Pregnant or breastfeeding;
• Participation in other clinical trials within 3 months of onset;
• Unsuitable for participating in this study judged by investigator.