The Efficacy and Safety of Sofadil for Injection in the Treatment of Acute Ischemic Stroke

Inclusion Criteria: * The target population is 35-75 years old, regardless of gender; * within 6h of onset, ischemic stroke of the internal carotid artery system; * Neurological deficits, including limb weakness, with acute brain injury (NIHSS score) (4-22 points), or NIHSS item 5 upper limb or 6 lower limb score ≥2 points; * Be able to initiate study treatment within 6 hours of onset of symptoms or within 6 hours of last appearing normal (6 hours after sleep in subjects with ischemic stroke who developed during sleep) and complete post-onset CT examination prior to study treatment; * Obtain the informed consent signed by the subject or the subject's legal representative; * MRS score before onset was 0\~1; * Patients with no history of myocardial infarction within 3 months; * Centerless, liver, kidney and lung dysfunction; * No hemorrhagic disease within 3 months; * No blood system diseases. Exclusion Criteria: * Any contraindications to CT or MRI (such as metal implants such as pacemaker, claustrophobia, etc * Stroke caused by posterior circulation ischemia, or TIA; * Acute intracranial hemorrhage, intracranial tumor, subarachnoid hemorrhage, encephalitis or other non-acute ischemic stroke (onset less than 6 hours), intracranial arteriovenous malformations; * Patients who plan to undergo endovascular treatment, such as mechanical thrombectomy, stenting or arteriovenous bridging, within 6 hours after onset; * Pregnant or lactating women. Note: The blood pregnancy test for fertile women before randomization must be negative and appropriate contraception should be used at least 3 weeks before randomization until 7 days after study drug infusion * A pre-existing medical, neurological or psychiatric disorder that confuses neurological, functional or imaging assessments, such as persistent injury from previous ischemic stroke; * Patients with malignant tumors or other critical diseases; * Having a history of epilepsy or having epileptiform symptoms at the onset of stroke; * Previous history of intracranial hemorrhage; * Patients with previous hypotension or blood pressure of less than 90/60mmhg measured for 3 consecutive times; * Patients with severe injuries and surgical history within 3 months; * People with consciousness disorder can be defined as "NIHSS score Ia ≥2 points"; * Bradycardia with complete atrioventricular block; * According to the New York heart association (NYHA) grade of cardiac function, cardiac function rating above Ⅱ level, a history of congestive heart failure (CHF). * Patients with primary liver and kidney diseases, AST or ALT twice as high as the normal upper limit, serum creatinine \>2.0 mg/dL or \>176.8 mol/L; * Where the INR is greater than 1.7 or where an oral anticoagulant is currently used, except aspirin, clopidogrel, subcutaneous heparin or Wartamine; * Patients with bleeding tendency diseases (such as hemophilia), and partial thromboplastin time (PTT) is more than 3 times of the normal upper limit; * Having a current drug or alcohol problem or experience; * Has the experience of allergic reaction to the research drugs or drugs with similar chemical structure; * Participated in other clinical trials or clinical study participants within 3 months before the start of this study; * The researcher considered it inappropriate to participate in the study.