Phase III Clinical Trial of Y-3 for Injection in the Treatment of Acute Ischemic Stroke - A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study

Phase 3

Recruiting

• Conditions: Acute ischemic stroke

• Registration Number: ChiCTR2400088762
• Lead Sponsor: Beijing Tiantan Hospital Affiliated to Capital Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age =18 years and <81 years, male or female;<br>2. After the onset of this event, the National Institutes of Health Stroke Scale score: 7 = NIHSS = 20, and the sum of the upper extremity and lower extremity scores of item 5 and item 6 is = 2;<br>3. The onset of the disease is within 48 hours (including 48 hours);<br>4. patients diagnosed with ischemic stroke according to Diagnostic Elements of Various Major Cerebrovascular Diseases in China 2019, with good healing after the first onset or after the last onset (mRS score =1 before this onset);<br>5. obtaining voluntary signed informed consent from the subjects or their legal representatives approved by the Ethics Committee.

Exclusion Criteria

1. intracranial hemorrhagic disease as seen on cranial imaging: hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.; if blood seepage only, enrollment may be appropriate at the discretion of the investigator;<br>2. severe impairment of consciousness: item score >1 on the NIHSS 1a level of consciousness;<br>3. transient ischemic attack (TIA);<br>4. patients with controlled blood pressure still = 220 mmHg systolic or = 120 mmHg diastolic;<br>5. patients with a previous diagnosis of severe mental disorder and patients with severe dementia;<br>6. patients with a previous diagnosis of depression or anxiety disorders;<br>7. patients undergoing antidepressant or anxiolytic treatment;<br>8. patients who have been diagnosed with severe active liver disease such as acute hepatitis, chronic active hepatitis, cirrhosis, etc.; or ALT or AST > 2.0ULN;<br>9. has been diagnosed with severe active renal disease, renal insufficiency; or serum creatinine >1.5ULN;<br>10. after this onset has been applied to the instructions have a brain cell protective effect of drugs, such as commercially available edaravone, edaravone dextran camphenol injection with concentrated solution, nimodipine, gangliosides, cytidine diphosphate choline, piracetam, olanzapine, butylphenyl peptide, human urokininogenase (euryculin), cinpirex, murine nerve growth factor, cerebral viability (encephalin hydrolysate), calf's blood deprivation of protein injections, Calf blood deproteinized extract injection, etc;<br>11. Thrombolysis or interventional therapy has been applied or is planned to be applied after the onset of this disease;<br>12. previous diagnosis of concomitant malignant tumors and undergoing anti-tumor therapy;<br>13. Previously diagnosed with severe systemic disease with an expected survival of <90 days;<br>14. the patient is pregnant, breastfeeding and the patient/patient's partner has the possibility of pregnancy and is planning to become pregnant during the trial period<br>15. patients with previously known hypersensitivity to the product or any of its excipients (polyethylene glycol 15-hydroxystearate, propylene glycol, mannitol, potassium dihydrogen phosphate, dipotassium hydrogen phosphate trihydrate);<br>16. history of major surgery within 4 weeks prior to enrollment and which, in the investigator's assessment, affects neurologic function scores or affects 90-day survival;<br>17. participation in another clinical study within 30 days prior to randomization or ongoing participation in another clinical study;<br>18. in the opinion of the investigator, not suitable for participation in this clinical study.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with mRS score =1 on treatment day 90;

Secondary Outcome Measures

Name	Time	Method
Good functional prognosis on day 90 of treatment;Analysis of mRS displacement on day 90 of treatment;Proportion of =4 reduction from baseline in NIHSS score on treatment days 10 and 30;Proportion with a Barthel Index score of =95 on the Activities of Daily Living Scale on treatment day 90;