The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship

Study Overview
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Brief Summary
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Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.

Official Title
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The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship

Conditions
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Cerebral Infarction

Intervention / Treatment
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* Drug: Human Urinary Kallidinogenase for Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 80 years old; First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2); Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology; Ability to randomize within 48 h of time last known free of new ischemic symptoms. National Institute of Health stroke scale(NIHSS) ranges from 7 to 22; signed written informed consent. Exclusion Criteria: Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.; Transient ischemic attack; Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8; Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI; Past or present suffering from hemorrhagic tendency of the disease; The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time. | Drug: Human Urinary Kallidinogenase for Injection<br>* Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time<br>* Other names: KLK;|
| Experimental: Control group<br>Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time. | Drug: Human Urinary Kallidinogenase for Injection<br>* Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time<br>* Other names: KLK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the decrease of National Institute of Health stroke scale(NIHSS) |  | 14 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Barthel Index |  | 90 Days | 
| the Modified Rankin Scale |  | 90 Days | 
| change of the National Institute of Health stroke scale |  | 8 Days | 
| the composite of ischemic vascular events | ischemic stroke, MI, or ischemic vascular death | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral infarction, kallikrein, KLK