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

Huisheng Chen

Status: Unknown

Conditions: Cerebral Infarction

Treatments: Drug: Human Urinary Kallidinogenase for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02806128

MAISKFE1.0

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Treatment group

Experimental group

Description:

Injection of Human Urinary Kallidinogenase for Injection (KLK) three times a day, 14 days . Patients need to complete laboratory tests within a specified time.

Treatment:

Drug: Human Urinary Kallidinogenase for Injection

Control group

Experimental group

Description:

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:

Drug: Human Urinary Kallidinogenase for Injection