Y-3 for Injection in the Treatment of Acute Ischemic Stroke
NCT Number: NCT06517173
Acronym: NUWA-Y3
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Acute Ischemic Stroke
Interventions: DRUG: Y-3 for injection|DRUG: Placebo control group
Sponsor: Beijing Tiantan Hospital
Collaborators: NeuroDawn Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 998
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-31
Completion Date: 2025-07
Locations: Beijing Tiantan Hospital Capital Medical University Beijing, Beijing, Beijing, 100000, China

Summary:
This trial aims to evaluate the effectiveness and safety of Y-3 for injection in the treatment of patients with acute ischemic stroke within 48 hours of onset

Primary Outcome Measures: The proportion of subjects with Modified Rankin Scale(mRS) score ≤ 1 on the 90th day of treatment, Measure the scores of subjects using the Modified Rankin Scale(mRS) scale.Measure on the 90th day of treatment to evaluate the effectiveness of the medication.The Modified Rankin Scale(mRS) score of this study ranged from 0 to 5. The higher the score, the worse the recovery, and the lower the score, the better the recovery., On the 90th day of treatment
Secondary Outcome Measures: Good functional prognosis on the 90th day of treatment, Modified Rankin Scale(mRS) score corrected based on baseline National Institute of Health stroke scale(NIHSS) score. The baseline National Institute of Health stroke scale(NIHSS) score of 4-7 is 0 on the 90 day Modified Rankin Scale(mRS) score; The baseline National Institute of Health stroke scale(NIHSS) score of 8-14 is 0-1 on a 90 day Modified Rankin Scale(mRS) score; The baseline National Institute of Health stroke scale(NIHSS) score is 15-25, with a 90 day Modified Rankin Scale(mRS) score of 0-2. Measure on the 90th day of treatment to evaluate the effectiveness of the medication., On the 90th day of treatment|Modified Rankin Scale(mRS) displacement analysis on the 90th day of treatment;, Measure the scores of subjects using the Modified Rankin Scale(mRS). Measure on the 90th day of treatment to evaluate the effectiveness of the medication.The Modified Rankin Scale(mRS) score of this study ranged from 0 to 5. The higher the score, the worse the recovery, and the lower the score, the better the recovery., On the 90th day of treatment|The proportion of National Institute of Health stroke scale(NIHSS) scores reduced by ≥ 4 compared to baseline on the 10th and 30th day of treatment;, Measure the scores of subjects using the National Institute of Health stroke scale(NIHSS). Measure on the 10th and 30th day of treatment to evaluate the effectiveness of the medication.National Institute of Health stroke scale(NIHSS) A larger difference from baseline means a better patient recovery, and a smaller difference means a worse patient recovery., On the 10th and 30th day of treatment|The proportion of individuals with Barthel Index score ≥ 95 on the 90th day of treatment on the Activities of Daily Living Scale., Measure the scores of subjects using the Barthel Index scale. Measure on the 90th day of treatment to evaluate the effectiveness of the medication.The total score of the Barthel Index is 100.The higher the Barthel Index scale score, the better the recovery, and the lower the score, the worse the recovery., On the 90th day of treatment