The objective of this clinical trial was to explore the efficacy and safety of Y-3 injection at different doses in patients with acute ischemic stroke within 48 hours of onset. A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants. Subjects press 1:1:1: 1 ratio of patients were randomly divided into Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60mg/ time, qd) and placebo control group, with 60 cases in each group. Random stratification factors include: Time of onset (≤24 hours, \> 24 hours). The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose. The trial was divided into three phases: screening/baseline, treatment, and follow-up. Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent. Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed. Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose. Stroke-related scale scores were performed at 10, 30, and 90 days after first use of the investigational drug The scores of Montgomery Depression Rating Scale (MSAS) and Hamilton Anxiety Scale (HAMA) were performed on the 10th and 90th days after the use of experimental drugs. Adverse events were recorded during treatment and follow-up to further assess safety
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design was designed to include 240 participants, who were randomly assigned to Y-3 low-dose group (20 mg/ time, qd), medium-dose group (40 mg/ time, qd), high-dose group (60 mg/ time, qd) and placebo control group in a ratio of 1:1:1:1. Each group had 60 cases. Random stratification factors included: onset time (≤24 hours, \> 24 hours).The patients were treated for 10 consecutive days (10 times) and followed up to 90 days after the first dose. The trial was divided into three phases:screening/baseline, treatment, and follow-up. Screening/baseline period: Subjects enter the screening/baseline period for screening examination after signing the informed consent.Treatment period: Eligible subjects were randomly assigned at a ratio of 1:1:1:1 to receive Y-3 injection low-dose group, medium-dose group, high-dose group and placebo control drug for 10 consecutive days (10 times), during which relevant examinations required by the protocol were conducted and safety was assessed.Follow-up period: Participants who finished treatment were followed up until 90 days after the first dose.Stroke-related scale scores were performed on the 10th, 30th and 90th days after the first use of the experimental drug, and Montgomery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAMA) scores were performed on the 10th and 90th days after the first use of the experimental drug. Adverse events were recorded during treatment and follow-up to further assess safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
240
The first dose should be completed as soon as possible after randomization; The time from the second dose to the first dose shall not be less than 12h, but not more than 24h+1h; The time interval of each subsequent administration is 24h±1h;
Beijing Tiantan Hospital, Capital Medical University Beijing
Beijing, Beijing Municipality, China
Liuzhou Workers Hospital
Liuchow, Guangxi, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Harrison International Peace Hospital
Hengshui, Hebei, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
Time frame: 90th day of treatment
Grade analysis of mRS Score on the 90th day of treatment;
Grade analysis of mRS Score on the 90th day of treatment;
Time frame: 90th day of treatment
The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;
The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;
Time frame: 90th day of treatment
Changes in NIH Stroke Scale from baseline on day 10 of treatment;
Changes in NIH Stroke Scale from baseline on day 10 of treatment;
Time frame: 10th day of treatment
Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.
Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.The content of NIHSS score included: consciousness level (consciousness level, consciousness level questioning, consciousness level command), gaze, visual field, facial paralysis, upper limb movement, lower limb movement, body aid movement, sensation, language, dysarthria, neglect. The score ranges from 0 to 42, with higher scores indicating more severe nerve damage.Score 0 to 1: normal or nearly normal Scores 1-4: mild stroke/minor stroke .5 to 15 points: moderate stroke .15-20 points: moderate to severe stroke Scores 21-42: severe stroke
Time frame: On the 10th and 30th day of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Daqing People's Hospital
Daqing, Heilongjiang, China
Nanyang Second People's Hospital
Nanyang, Henan, China
Nanyang South Stone Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
...and 20 more locations