Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The Favorable Stroke Outcome of 90 days
研究概览
简要总结
The goal of this clinical trial is to explore the changes in the expression levels of inflammatory factors before and after the early treatment of Human Urinary Kallidinogen (HUK) in the acute ischemic stroke. It will also learn about the correlation between inflammatory factors and AIS prognosis, in order to clarify the efficacy and safety of Urinary Kallidinogen in the acute phase of AIS.
详细描述
The study process lasts for a total of 90 days, including the screening period, treatment period, and follow-up period. During the treatment period, the experimental group is treated with HUK in the 48 hours of AIS plus routine clinical treatment, while the control group receives routine clinical treatment group for 7 days.All patients are followed up until the 90th day after stroke. The sample size of the study is 200 patients. The ratio of the experimental group to the control group was 1:1.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;
- •First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
- •Age≥18 years, male or female;
- •3≤Baseline NIHSS≤25;
- •Written informed consent obtained from the patient or legally responsible person.
排除标准
- •Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
- •Previously allergic or intolerant to injectable HUK；
- •Used ACEI drugs prior to medication and less than 5 half-lives of the drug (according to the specific drug instructions) or received ACEI drugs during the study period;
- •Stent surgery after the AIS onset or planned interventional therapy;
- •Pregnancy, lactation or planned pregnancy；
- •Life expectancy of less than 3months or inability to complete the study for other reasons；
- •Unwilling to be followed up or poor compliance；
- •Current participation in other clinical research;
- •Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).
研究组 & 干预措施
Human Urinary Kallidinogenase for injection (HUK)
Patients in this arm will be given urinary kallidinogenase for injection，0.15 peptide nucleic acids (PNA)， once a day for 7days plus routine clinical treatment
干预措施: Human urinary kininogenase(HUK) (Drug)
sham-HUK treatment
Normal sodium chloride injection plus routine clinical treatment
干预措施: Placebo (Other)
结局指标
主要结局
The Favorable Stroke Outcome of 90 days
时间窗: 90 days after treatment
mRS 0-2
The changes of the serum inflammatory markers before and after treatment
时间窗: Baseline、1 day after treatment、3 days after treatment、90 days after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
次要结局
- The changes of NIHSS before and after treatment(Baseline、7 days after treatment)
- Stroke recurrence rate(90 days after treatment)
- The incidence of intracranial hemorrhage(90 days after treatment)
研究者
Zhongling Zhang
Doctor
First Affiliated Hospital of Harbin Medical University