Phase 4 N=80 Randomized Treatment

Human Urinary Kallidinogenase Improve Short Term Motor Functional Outcome of Acute Ischemia Stroke Patients

Stroke, Acute

Bottom Line

View on ClinicalTrials.gov: NCT04102956 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Myelin Basic Protein (MBP) Comparison Between the Two Groups Before and After Treatment — 0.42; 0.64; 0.41; 0.71 pg/ml

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Kallikrein (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: The Second Hospital of Hebei Medical University
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Myelin Basic Protein (MBP) Comparison Between the Two Groups Before and After Treatment	0.42; 0.64; 0.41; 0.71	—
PRIMARY Comparison of Vascular Endothelial Growth Factor (VEGF) Before and After Treatment Between the Kallikrein+Standard Treatment Group and Standard Treatment Group	22.42; 22.56; 29.53; 22.91	—
PRIMARY Changes of Barthel Index(BI) Before and After Treatment in the Two Groups	17.5; 12.5	—
PRIMARY Changes in Muscle Strength of the Kallikrein+Standard Treatment Group and the Standard Treatment Group Before and After Treatment	1; 1	—
PRIMARY Changes of National Institute of Health Stroke Scale(NIHSS) Before and After Treatment in the Two Groups	2.88; 2.16	—
PRIMARY Change of Fractional Anisotropy Valuev Decline Rate† (FA Decline Rate†)	0.036; 0.09	—
PRIMARY Change of Apparent Diffusion Coefficient Value Decline Rate‡（ADC Decline Rate‡）	-0.02; 0.03	—

Summary

Acute cerebral infarction is a common type of ischemic stroke, causing brain dysfunction in patients with high morbidity and disability. With the changes in people's diet, lifestyle patterns and population aging, the incidence of acute cerebral infarction has increased year by year, which has become an important cause of disability and death in middle-aged and elderly patients. The human urinary kallidinogenase (HUK) was used in China in the management of acute ischemic stroke (AIS) in recent years. However, the mechanism of HUK on AIS has not been systematically investigated. This study aimed to assess the effect of HUK on motor functional outcome and relative corticospinal tract recovery in the patients with AIS. Diffusion tensor imaging(DTI) and diffusion tensor tractography(DTT) have all been used to observe features of cerebral white matter fibrous structures. In addition, diffusion tensor tractography which is used to trace fiber bundle and evaluate white matter fiber bundle integrity and direction is the only non-invasive imaging method to display the corticospinal tract in vivo.

Eligibility Criteria

Inclusion Criteria

18 years old ≤ age <80 years old; Within 72 hours of onset; Diagnosed as acute cerebral infarction, and confirmed by magnetic resonance imaging as an acute infarct in the unilateral corticospinal tract; The patient's onset muscle strength grade <4; No history of cerebral infarction or residual physical activity disorder; No other intracranial lesions; Patients or their legal representatives voluntarily Sign the informed consent form;

Exclusion Criteria

Intracranial hemorrhagic disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.; Transient ischemic attack; Intravenous thrombolysis and interventional thrombectomy; Serious physical illness affects limb movement before enrollment ; Apply other drugs with nutritional nerves and regeneration during the study period; Unstable vital signs, severe liver and kidney diseases or malignant tumors; Incomprehensible or incapable of obeying the research procedure or being unable to follow up due to mental illness, cognitive or emotional disorders;

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Data sourced from ClinicalTrials.gov (NCT04102956). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.