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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02806128
Acronym
MAISKFE
Enrollment
100
Registered
2016-06-20
Start date
2016-11-30
Completion date
Unknown
Last updated
2017-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Infarction

Keywords

cerebral infarction, kallikrein, KLK

Brief summary

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

Interventions

DRUGHuman Urinary Kallidinogenase for Injection

Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time

Sponsors

Huisheng Chen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
the decrease of National Institute of Health stroke scale(NIHSS)14 Days

Secondary

MeasureTime frameDescription
the Barthel Index90 Days
the Modified Rankin Scale90 Days
change of the National Institute of Health stroke scale8 Days
the composite of ischemic vascular events90 Daysischemic stroke, MI, or ischemic vascular death

Countries

China

Contacts

Primary ContactHuisheng Chen
chszh@aliyun.com86-24-28897511
Backup Contactzhonghe Zhou
Zhouz.h@tom.com86-24-28897511

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026