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

January 5, 2017 updated by: Huisheng Chen
Evaluate the effectiveness of the of kallikrein in the different drug frequency for acute anterior circulation cerebral infarction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110840
        • Recruiting
        • General Hospital of Shenyang Military Region
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Other Names:
  • KLK
Experimental: 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.
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
Other Names:
  • KLK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the decrease of National Institute of Health stroke scale(NIHSS)
Time Frame: 14 Days
14 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the Barthel Index
Time Frame: 90 Days
90 Days
the Modified Rankin Scale
Time Frame: 90 Days
90 Days
change of the National Institute of Health stroke scale
Time Frame: 8 Days
8 Days
the composite of ischemic vascular events
Time Frame: 90 Days
ischemic stroke, MI, or ischemic vascular death
90 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huisheng Chen

Investigators

  • Study Chair: Huisheng Chen, General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 10, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 5, 2017

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAISKFE1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

After the completion of clinical trials ，Through the article published and upload data 。

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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