Aleeto in Acute ISchemic Stroke：A RandomISed Controlled Clinical Trial
Trial Parameters
Brief Summary
This study is a prospective, double-blind, 1:1:1 randomized controlled study aimed at evaluating the efficacy and safety of Aleeto treatment compared to placebo in improving the NIHSS score at 14 days in patients with moderate to severe acute ischemic stroke. It also aims to explore the neuroprotective effects of Aleeto in moderate to severe acute ischemic stroke and provide data support and evidence for future clinical trials and evidence-based medicine.
Eligibility Criteria
Inclusion Criteria: 1. Age between 30 and 80 years (30 ≤ age ≤ 80). 2. Diagnosis of acute ischemic stroke confirmed by CT or MRI, according to the "Key Points for Diagnosis of Major Cerebrovascular Diseases in China 2019." 3. Time from symptom onset ≤ 72 hours. 4. NIHSS score between 6 and 24, with a score of ≥ 1 on items 5 and 6 of the NIHSS. 5. Pre-stroke mRS (modified Rankin Scale) \< 2, indicating independent activities of daily living. 6. Signed informed consent. Exclusion Criteria: 1. Intracranial hemorrhagic diseases identified by head CT: cerebral hemorrhage, extradural hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, etc. 2. Combined with other active and major neurological diseases (such as induced seizures, poor drug control of recurrent seizures, multiple sclerosis, intracranial tumors, etc.). 3. History of infectious diseases (HIV positive or positive test history, HCV antibody positive or positive test history, HBV surface antigen positive and/or serum HB