Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke (KIF-AIS)

Harbin Medical University

Status: Enrolling

Conditions: Acute Ischemic Stroke

Treatments: Drug: Human urinary kininogenase(HUK); Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06696703

2023155

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis as acute ischemic stroke according to the Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018;
2. First clinical onset or previous presence of cerebral infarction without severe sequelae（Premorbid mRS ≤2）
3. Age≥18 years, male or female;
4. 3≤Baseline NIHSS≤25;
5. Written informed consent obtained from the patient or legally responsible person.

Exclusion criteria

1. Cerebral hemorrhage and the acute phase of other hemorrhagic diseases；
2. Previously allergic or intolerant to injectable HUK；
3. 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;
4. Stent surgery after the AIS onset or planned interventional therapy;
5. Pregnancy, lactation or planned pregnancy；
6. Life expectancy of less than 3months or inability to complete the study for other reasons；
7. Unwilling to be followed up or poor compliance；
8. Current participation in other clinical research;
9. Other causes of AIS (such as dissection, vasculitis, pre-thrombotic lesions, drug abuse).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Human Urinary Kallidinogenase for injection (HUK)

Experimental group

Description:

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

Treatment:

Drug: Human urinary kininogenase(HUK)

sham-HUK treatment

Placebo Comparator group

Description:

Normal sodium chloride injection plus routine clinical treatment

Treatment:

Other: Placebo