The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
NCT ID: NCT02806128
Last Updated: 2017-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment group
Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
Human Urinary Kallidinogenase for Injection
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
Control group
Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
Human Urinary Kallidinogenase for Injection
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
Interventions
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Human Urinary Kallidinogenase for Injection
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. First time diagnosed or have history of acute anterior circulation cerebral infarction without serious sequelae (mRS = 0-2);
3. Acute anterior circulation cerebral infarction with large artery atherosclerotic etiology;
4. Ability to randomize within 48 h of time last known free of new ischemic symptoms.
5. National Institute of Health stroke scale(NIHSS) ranges from 7 to 22;
6. signed written informed consent.
Exclusion Criteria
2. Transient ischemic attack;
3. Serious disturbance of consciousness: Glasgow Coma ScaleGCS（GCS）≤8;
4. Combined angiotensin-converting enzyme inhibitor(ACEI) less than 5 half-time (according to its instruction), or need to be treated with ACEI;
5. Past or present suffering from hemorrhagic tendency of the disease;
6. The investigator in consideration of the other condition that the patients doesn't fit to participate in this clinical study.
18 Years
80 Years
ALL
No
Sponsors
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Huisheng Chen
OTHER
Responsible Party
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Huisheng Chen
Principal Investigator
Principal Investigators
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Huisheng Chen
Role: STUDY_CHAIR
General Hospital of Shenyang Military Region
Locations
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General hospital of shenyang military region
Shenyang, Liaoning, China
Countries
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Central Contacts
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Facility Contacts
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References
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Xia CF, Yin H, Borlongan CV, Chao L, Chao J. Kallikrein gene transfer protects against ischemic stroke by promoting glial cell migration and inhibiting apoptosis. Hypertension. 2004 Feb;43(2):452-9. doi: 10.1161/01.HYP.0000110905.29389.e5. Epub 2003 Dec 29.
Xia CF, Smith RS Jr, Shen B, Yang ZR, Borlongan CV, Chao L, Chao J. Postischemic brain injury is exacerbated in mice lacking the kinin B2 receptor. Hypertension. 2006 Apr;47(4):752-61. doi: 10.1161/01.HYP.0000214867.35632.0e. Epub 2006 Mar 13.
Xia CF, Yin H, Yao YY, Borlongan CV, Chao L, Chao J. Kallikrein protects against ischemic stroke by inhibiting apoptosis and inflammation and promoting angiogenesis and neurogenesis. Hum Gene Ther. 2006 Feb;17(2):206-19. doi: 10.1089/hum.2006.17.206.
Chen ZB, Huang DQ, Niu FN, Zhang X, Li EG, Xu Y. Human urinary kallidinogenase suppresses cerebral inflammation in experimental stroke and downregulates nuclear factor-kappaB. J Cereb Blood Flow Metab. 2010 Jul;30(7):1356-65. doi: 10.1038/jcbfm.2010.19. Epub 2010 Feb 24.
Other Identifiers
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MAISKFE1.0
Identifier Type: -
Identifier Source: org_study_id
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