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.
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;
3≤Baseline NIHSS≤25;
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;
Parallel
Human urinary kininogenase(HUK)
DrugExperimental 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.
Placebo
Other interventionPlacebo 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.
The Favorable Stroke Outcome of 90 days
mRS 0-2
The changes of the serum inflammatory markers before and after treatment
Complete Blood Count、CRP、IL-6、HCY、NSE
The changes of NIHSS before and after treatment
National Institute of Health stroke scale, NIHSS
Stroke recurrence rate
Ischemic stroke
The incidence of intracranial hemorrhage
Symptomatic intracranial hemorrhage
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