The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
MAISKFE
1 other identifier
interventional
100
1 country
1
Brief Summary
Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedJanuary 6, 2017
August 1, 2016
2.1 years
June 10, 2016
January 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the decrease of National Institute of Health stroke scale(NIHSS)
14 Days
Secondary Outcomes (4)
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
90 Days
Study Arms (2)
Treatment group
EXPERIMENTALInjection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Control group
EXPERIMENTALInjection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Interventions
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Huisheng Chenlead
Study Sites (1)
General hospital of shenyang military region
Shenyang, Liaoning, 110840, China
Related Publications (4)
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.
PMID: 14698996BACKGROUNDXia 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.
PMID: 16534002BACKGROUNDXia 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.
PMID: 16454654BACKGROUNDChen 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.
PMID: 20179726BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huisheng Chen
General Hospital of Shenyang Military Region
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 20, 2016
Study Start
November 1, 2016
Primary Completion
December 1, 2018
Last Updated
January 6, 2017
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will share
After the completion of clinical trials ，Through the article published and upload data 。