Y-3 Injection in the Treatment of Acute Ischemic Stroke Phase II Clinical Trial -- Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 30
- 主要终点
- The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
In a double-blind design, the researchers, the researchers involved in the trial effect evaluation, the data managers, the statistical analysts, and the subjects and their relatives or guardians were blind to the treatment groups.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Those who meet one of the following criteria during filtering cannot be included in the group:
- •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;
- •Transient ischemic attack (TIA);
- •After controlling the patient's blood pressure, the systolic blood pressure remains ≥ 220mmHg or the diastolic blood pressure remains ≥ 120mmHg;
- •Previously diagnosed patients with severe mental disorders and severe dementia;
- •Patients previously diagnosed with depression or anxiety disorder;
- •Patients undergoing antidepressant or anti anxiety treatment;
- •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;
- •After the onset of this disease, thrombectomy or interventional therapy has been applied or planned to be applied;
- •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;
- •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;
- •Previously known allergies to this product or any of its excipients (15-hydroxystearic acid polyethylene glycol ester, propylene glycol, sodium hydroxide);
- •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;
- •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.
研究组 & 干预措施
Y-3 low-dose group (20 mg/dose, qd)
Y-3 injection 20mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
干预措施: Y-3 Injection/Y-3 blank injection (Drug)
Y-3 medium dose group (40 mg/dose, qd)
Y-3 injection 40mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
干预措施: Y-3 Injection/Y-3 blank injection (Drug)
Y-3 high-dose group (60 mg/dose, qd)
Y-3 injection 60mg diluted with about 250 ml normal saline, intravenous infusion, qd, continuous medication for 10 days.
干预措施: Y-3 Injection/Y-3 blank injection (Drug)
Blank control group
Y-3 blank injection 10ml was diluted with about 250 ml normal saline, intravenous infusion, qd, and continuous medication for 10 days.
干预措施: Y-3 Injection/Y-3 blank injection (Drug)
结局指标
主要结局
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
时间窗: 90th day of treatment
The proportion of subjects with mRS score ≤ 1 on the 90th day of treatment .
次要结局
- Grade analysis of mRS Score on the 90th day of treatment;(90th day of treatment)
- Proportion of NIH Stroke of 0-1 or ≥4 reduction from baseline on day 10 and day 30 of treatment.(On the 10th and 30th day of treatment)
- Changes in NIH Stroke Scale from baseline on day 10 of treatment;(10th day of treatment)
- The proportion of subjects with mRS Score ≤2 on the 90th day of treatment;(90th day of treatment)
研究者
Yongjun Wang
Chief Physician
Beijing Tiantan Hospital