Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial

Prior treatment

• Previously diagnosed patients with severe mental disorders and severe dementia;
• Patients previously diagnosed with depression or anxiety disorder;
• Previously diagnosed with concurrent malignant tumors and undergoing anti-tumor treatment;
• Previously diagnosed with severe systemic diseases, with an estimated survival period of\<90 days;
• A history of major surgeries within 4 weeks prior to enrollment and assessed by the researcher as affecting neurological function scores or affecting 90 day survival;

Other illness

• Intracranial hemorrhagic diseases seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc; If it is only oozing blood, the researcher can determine whether it is suitable for enrollment;
• Severe consciousness disorder: The item score of NIHSS's 1a consciousness level is greater than 1 point;
• After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;

Lab values

• Diagnosed with severe active liver diseases, such as acute hepatitis, chronic active hepatitis, liver cirrhosis, etc; Or ALT or AST\>2.0 × ULN;
• Diagnosed with severe active kidney disease or renal insufficiency; Or serum creatinine\>1.5 × ULN;
• After the onset of the disease, drugs with brain cytoprotection in the instructions have been used, such as edaravone, concentrated solution of edaravone and dextranol for injection, nimodipine, ganglioside, CDPC, piracetam, oxiracetam, butylphenylpeptide, human urinary kallidinogenase (Urinary Kallidinogenase), cinepazide, rat nerve growth factor, cerebrolysin (cerebroprotein hydrolysate), calf serum deproteinized injection Calf blood deproteinized extract injection, etc;
• Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide);

Other

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• Those who meet one of the following criteria during filtering cannot be included in the group:
• Transient ischemic attack (TIA);
• After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
• Patients undergoing antidepressant or anti anxiety treatment;
• The patient is in pregnancy, lactation, and there is a possibility of pregnancy in the patient/patient partner who plans to conceive during the trial period;
• Have participated in other clinical studies or are currently participating in other clinical studies within the first 30 days of randomization;
• The researcher believes that it is not suitable to participate in this clinical study.

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• Only those who meet all the following criteria can be included in the group:
• Age ≥ 18 years old and\<81 years old, regardless of gender;
• After the onset of this disease, the National Institutes of Research Stroke Scale score was 6 ≤ NIHSS ≤ 20 points, and the sum of the 5th upper limb and 6th lower limb scores was ≥ 2 points. If patients receiving thrombolysis treatment were screened and evaluated based on the NIHSS score after thrombolysis;
• Within 48 hours (including 48 hours) of onset;
• Diagnosed as ischemic stroke according to the "Key Diagnostic Points for Various Major Cerebrovascular Diseases in China 2019", with good recovery after the first or last onset (mRS score ≤ 1 point before this onset);
• Obtain informed consent from the patient or their legal representative voluntarily signed and approved by the ethics committee.