Multi-modality MRI Study on Effect to Collateral Circulation and Blood Perfusion of Acute Cerebral Infarction by Human Urinary Kallidinogenase

NCT ID: NCT02259738

Last Updated: 2014-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-06-30

Brief Summary

Human urinary kallidinogenase can promote the establishment of collateral circulation in the ischemic penumbra due to the stenosis or occlusion of middle cerebral artery and then increase the perfusion.

Detailed Description

Patients with acute ischemic stroke will be given human urinary kallidinogenase .Then we will estimate the cerebral collateral circulation in ischemic regions and final infarct volume, comparing with traditional therapy such as Shuxuening injection, which will provide new evidence for the treatment of ischemic stroke. Perfusion Weighted Imaging(PWI) could be a method to reflect the infarction center and low perfusion of tissue.

Conditions

Cerebral Infarction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Human urinary kallidinogenase and Shuxuening injection

Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.

Group Type: EXPERIMENTAL

Human Urinary Kallidinogenase

Intervention Type: DRUG

Shuxuening injection

Intervention Type: DRUG

Interventions

Human Urinary Kallidinogenase

Intervention Type: DRUG

Shuxuening injection

Intervention Type: DRUG

Other Intervention Names

youruikelin

Eligibility Criteria

Inclusion Criteria

• Age:greater than or equal to 18 years old and less than or equal to 70 years old;
• Time of onset is less than 7 days;
• Acute cerebral infarction due to the stenosis or occlusion of middle cerebral artery diagnosed by CT or MRI;
• The National Institute of Health Stroke Scale(NIHSS) score is 4 to 20;
• Excluding intracranial hemorrhage using CT or MRI.

Exclusion Criteria

• The NIHSS score is less than or equal to 3;
• Patients with cerebral aneurysm, cerebral hemorrhage, brain tumor, brain contusion and laceration of brain and other diseases;
• Intracranial hemorrhage displaying by CT or MRI; Cardiac insufficiency;
• Cardiac insufficiency;
• Chronic liver disease(A/G inversion),elevated alanine aminotransferase(ALT)(more than 1.5 times the normal value);
• Increased serum creatinine(more than 1.5 times the normal value);
• Poorly controlled diabetes;
• Recently suffered from hemorrhagic disease or bleeding tendency;
• Recent use of angiotensin-converting enzyme inhibitor (ACEI) drugs;
• Allergic constitution and had a variety of drug allergy history;
• Women in period of pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

XuanwuH 2

OTHER

Sponsor Role: lead

Responsible Party

XuanwuH 2

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

hanying1

Identifier Type: -

Identifier Source: org_study_id