NCT02806128Unknown不适用
The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Huisheng Chen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the decrease of National Institute of Health stroke scale(NIHSS)
研究概览
简要总结
Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.
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
- None
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
- •Age 18 to 80 years old;
- •First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);
- •Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;
- •Ability to randomize within 48 h of time last known free of new ischemic symptoms.
- •National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;
- •signed written informed consent.
排除标准
- •Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
- •Transient ischemic attack;
- •Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
- •Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;
- •Past or present suffering from hemorrhagic tendency of the disease;
- •The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study.
研究组 & 干预措施
Treatment group
Experimental
Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
干预措施: Human Urinary Kallidinogenase for Injection (Drug)
Control group
Experimental
Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
干预措施: Human Urinary Kallidinogenase for Injection (Drug)
结局指标
主要结局
the decrease of National Institute of Health stroke scale(NIHSS)
时间窗: 14 Days
次要结局
- the Barthel Index(90 Days)
- the Modified Rankin Scale(90 Days)
- change of the National Institute of Health stroke scale(8 Days)
- the composite of ischemic vascular events(90 Days)
研究者
Huisheng Chen
Principal Investigator
General Hospital of Shenyang Military Region
研究点 (1)
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