Back to resultsThe Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship (MAISKFE)
Primary Purpose
Cerebral Infarction
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Human Urinary Kallidinogenase for Injection
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Infarction focused on measuring cerebral infarction, kallikrein, KLK
Eligibility Criteria
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.
Sites / Locations
- General hospital of shenyang military regionRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Treatment group
Control group
Arm Description
Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Outcomes
Primary Outcome Measures
the decrease of National Institute of Health stroke scale(NIHSS)
Secondary Outcome Measures
the Barthel Index
the Modified Rankin Scale
change of the National Institute of Health stroke scale
the composite of ischemic vascular events
ischemic stroke, MI, or ischemic vascular death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02806128
Brief Title
The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Acronym
MAISKFE
Official Title
The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Huisheng Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
cerebral infarction, kallikrein, KLK
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
Arm Title
Control group
Arm Type
Experimental
Arm Description
Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days .
Patients need to complete laboratory tests within a specified time.
Intervention Type
Drug
Intervention Name(s)
Human Urinary Kallidinogenase for Injection
Other Intervention Name(s)
KLK
Intervention Description
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
Primary Outcome Measure Information:
Title
the decrease of National Institute of Health stroke scale(NIHSS)
Time Frame
14 Days
Secondary Outcome Measure Information:
Title
the Barthel Index
Time Frame
90 Days
Title
the Modified Rankin Scale
Time Frame
90 Days
Title
change of the National Institute of Health stroke scale
Time Frame
8 Days
Title
the composite of ischemic vascular events
Description
ischemic stroke, MI, or ischemic vascular death
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huisheng Chen
Phone
86-24-28897511
Email
chszh@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
zhonghe Zhou
Phone
86-24-28897511
Email
Zhouz.h@tom.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisheng Chen
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Study Chair
Facility Information:
Facility Name
General hospital of shenyang military region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hou Xiaowen, Master
Phone
862428897511
Ext
15840240196
Email
sophia_hxw@163.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the completion of clinical trials ，Through the article published and upload data 。
Citations:
PubMed Identifier
14698996
Citation
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.
Results Reference
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PubMed Identifier
16534002
Citation
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.
Results Reference
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PubMed Identifier
16454654
Citation
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.
Results Reference
background
PubMed Identifier
20179726
Citation
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.
Results Reference
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The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
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