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

Not Applicable

• Conditions: Cerebral Infarction
• Interventions: Drug: Human Urinary Kallidinogenase for Injection

• Registration Number: NCT02806128
• Lead Sponsor: Huisheng Chen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-20
• Status Verified: 2016-08
• Study Start: 2016-11
• Last Update Submitted: 2017-01-05
• Last Update Posted: 2017-01-06
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Human Urinary Kallidinogenase for Injection	Injection of Human Urinary Kallidinogenase for Injection (KLK) Once times a day, 14 days . Patients need to complete laboratory tests within a specified time.
Treatment group	Human Urinary Kallidinogenase for Injection	Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.

Primary Outcome Measures

Name	Time	Method
the decrease of National Institute of Health stroke scale(NIHSS)	14 Days

Secondary Outcome Measures

Name	Time	Method
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	ischemic stroke, MI, or ischemic vascular death

Trial Locations

Locations (1)

General hospital of shenyang military region; 🇨🇳 Shenyang, Liaoning, China