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

November 19, 2024 updated by: Zhongling Zhang, First Affiliated Hospital of Harbin Medical University

Effect of Human Urinary Kallidinogenase on Inflammatory Factors in Acute Ischemic Stroke: a Single-center, Randomized, Open Label, Blinded-endpoint, Controlled Study(KIF-AIS)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Recruiting
        • Zhongling Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: 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.
Other Names:
  • Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065
Placebo Comparator: sham-HUK treatment
Normal sodium chloride injection plus routine clinical treatment
Other: 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.
Other Names:
  • Normal sodium chloride injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Favorable Stroke Outcome of 90 days
Time Frame: 90 days after treatment
mRS 0-2
90 days after treatment
The changes of the serum inflammatory markers before and after treatment
Time Frame: Baseline、1 day after treatment、3 days after treatment、90 days after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
Baseline、1 day after treatment、3 days after treatment、90 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of NIHSS before and after treatment
Time Frame: Baseline、7 days after treatment
National Institute of Health stroke scale, NIHSS
Baseline、7 days after treatment
Stroke recurrence rate
Time Frame: 90 days after treatment
Ischemic stroke
90 days after treatment
The incidence of intracranial hemorrhage
Time Frame: 90 days after treatment
Symptomatic intracranial hemorrhage
90 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Harbin Medical University

Investigators

  • Principal Investigator: Zhongling Zhang, First Affiliated Hospital, Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 16, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Estimated)

November 20, 2024

Study Record Updates

Last Update Posted (Estimated)

November 20, 2024

Last Update Submitted That Met QC Criteria

November 19, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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