Clinical trial NCT02806128: The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Official title: The Metabolism Research of KLK Treating Acute Cerebral Ischemic Stroke: Focus on Drug Frequency-Efficacy Relationship
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Infarction
Keywords: cerebral infarction
kallikrein
KLK
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 80 years old;
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:

1. Cerebral CT shows cerebral hemorrhage disease: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
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.

Primary outcomes:
measure: the decrease of National Institute of Health stroke scale(NIHSS)
timeFrame: 14 Days
Secondary outcomes:
measure: the Barthel Index
timeFrame: 90 Days
measure: the Modified Rankin Scale
timeFrame: 90 Days
measure: change of the National Institute of Health stroke scale
timeFrame: 8 Days
measure: the composite of ischemic vascular events
timeFrame: 90 Days
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General hospital of shenyang military region
state: Liaoning
Study officials:
affiliation: General Hospital of Shenyang Military Region
name: Huisheng Chen
role: STUDY_CHAIR
References:
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.
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.
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.
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.