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

NCT06696703 | Recruiting DMC

• 1 other identifier: 2023155
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

Acute ischemic stroke; Urinary Kallidinogen; Inflammatory factors; 90 days functional outcomes

Outcome Measures

Primary Outcomes (2)

• The Favorable Stroke Outcome of 90 days

  mRS 0-2

  90 days after treatment

• The changes of the serum inflammatory markers before and after treatment

  Complete Blood Count、CRP、IL-6、HCY、NSE

  Baseline、1 day after treatment、3 days after treatment、90 days after treatment

Secondary Outcomes (3)

• 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

Study Arms (2)

Human Urinary Kallidinogenase for injection (HUK)

EXPERIMENTAL

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)

sham-HUK treatment

PLACEBO COMPARATOR

Normal sodium chloride injection plus routine clinical treatment

Other: Placebo

Interventions

Human urinary kininogenase(HUK) 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.

Also known as: Urinary Kallidinogenase for Injection,Guangdong Tianpu Biochemical Pharmaceutical Co., Ltd, National Pharmaceutical Approval Letter H20052065

Human Urinary Kallidinogenase for injection (HUK)

Placebo 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.

Also known as: Normal sodium chloride injection

sham-HUK treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ≤Baseline NIHSS≤25;
• Written informed consent obtained from the patient or legally responsible person.

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Zhongling Zhang

Harbin, Heilongjiang, 150001, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Injections; Long-Term Synaptic Depression

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Neuronal Plasticity; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Zhongling Zhang

  First Affiliated Hospital, Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongling Zhang

CONTACT

+8613503615988; zhang777hyd@163.com

shanshan yang

CONTACT

+8613845104003; yangshanshan81@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 16, 2024
• First Posted: November 20, 2024
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CN (1)