NCT02526225已完成2 期
A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.
Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 3,452 人开始时间: 2016年2月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,452
- 试验地点
- 1
- 主要终点
- Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
研究概览
简要总结
The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
详细描述
After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
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
- Triple (Participant, Care Provider, Investigator)
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
- •Aged 18 to 80 years of age, and gender not limited。
- •Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
- •The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- •The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher;
- •Understand and voluntarily signed informed consent.
排除标准
- •Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- •The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
- •With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
- •Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5);
- •A history of mental illness or dementia patients;
- •Severe organ or other systemic disease, accompanied by any organ or system of malignant tumor, or ongoing anti-tumor treatment, the estimated lifetime < 3 months;
- •Significant drug or alcohol abuse;
- •Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known;
- •Have pregnancy (check blood HCG positive screening tests, namely HCG > 5 miu/mL), during the test preparation is pregnancy or lactation in women;
- •In the past three months in other clinical trials;
- •Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.
研究组 & 干预措施
ginkgo diterpene lactone meglumine injection
Active Comparator
ginkgo diterpene lactone meglumine injection
干预措施: Ginkgo diterpene lactone meglumine injection (Drug)
Ginkgo diterpene lactone meglumine injection simulation
Placebo Comparator
Ginkgo diterpene lactone meglumine injection simulation
干预措施: Ginkgo diterpene lactone meglumine injection simulation (Drug)
结局指标
主要结局
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
时间窗: 90 days
次要结局
- Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days.(Baseline, 7days)
- Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .(90 days)
- Ischemic stroke recurrence rate(90 days)
- Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days.(Baseline,7 days,14 days,)
- The all-cause mortality(90 days)
- The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.(Baseline,14 days,90 days)
- The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.(Baseline,14 days,90 days)
- Composite incidence of vascular events(90 days)
研究者
Yongjun Wang
Executive Vice-President
Beijing Tiantan Hospital
研究点 (1)
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