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

Cerebral Infarction Clinical Trial

— MAISKFE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02806128
• Other study ID #: MAISKFE1.0
• Status: Recruiting
• Phase: N/A
• First received: June 10, 2016
• Last updated: January 5, 2017
• Start date: November 2016

Study information

• Verified date: August 2016
• Source: General Hospital of Shenyang Military Region
• Contact: Huisheng Chen
• Phone: 86-24-28897511
• Email: chszh[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Infarction
• Infarction

Intervention

Drug:
• Human Urinary Kallidinogenase for Injection
Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time

Locations

Country	Name	City	State
China	General hospital of shenyang military region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Huisheng Chen

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the decrease of National Institute of Health stroke scale(NIHSS)		14 Days	No
Secondary	the Barthel Index		90 Days	No
Secondary	the Modified Rankin Scale		90 Days	No
Secondary	change of the National Institute of Health stroke scale		8 Days	No
Secondary	the composite of ischemic vascular events	ischemic stroke, MI, or ischemic vascular death	90 Days	No