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

NCT ID: NCT06696703

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-12-01

Brief Summary

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.

Detailed 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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Human urinary kininogenase(HUK)

Intervention Type: DRUG

Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day.

sham-HUK treatment

Normal sodium chloride injection plus routine clinical treatment

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day.

Interventions

Human urinary kininogenase(HUK)

Experimental group (HUK plus routine clinical treatment): administered within 48 hours of AIS onset, 0.15PNA unit was dissolved in 100ml sodium chloride injection by intravenous infusion for not less than 50 minutes, once a day.

Intervention Type: DRUG

Placebo

Placebo group (Normal sodium chloride injection plus routine clinical treatment): Normal sodium chloride administered within 48 hours of AIS onset, by intravenous infusion for not less than 50 minutes, once a day.

Intervention Type: OTHER

Other Intervention Names

Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065; Normal sodium chloride injection

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhongling Zhang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhongling Zhang

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Harbin Medical University

Locations

Zhongling Zhang

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhongling Zhang

Role: CONTACT

zhang777hyd@163.com

+8613503615988

shanshan yang

Role: CONTACT

yangshanshan81@163.com

+8613845104003

Facility Contacts

Zhongling Zhang

Role: primary

zhang777hyd@163.com

+8613503615988

Other Identifiers

2023155

Identifier Type: -

Identifier Source: org_study_id