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

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Sofadil; Acute ischemic stroke Read More

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.