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

Phase 2

Completed

• Conditions: Cerebral Infarction
• Interventions: Drug: Human Urinary Kallidinogenase; Drug: Shuxuening injection

• Registration Number: NCT02259738
• Lead Sponsor: XuanwuH 2

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted: 2014-09-16
• Status Verified: 2014-10
• Study First Submitted QC: 2014-10-04
• Last Update Submitted: 2014-10-04
• Study First Posted: 2014-10-08
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human urinary kallidinogenase and Shuxuening injection	Human Urinary Kallidinogenase	Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.
Human urinary kallidinogenase and Shuxuening injection	Shuxuening injection	Human urinary kallidinogenase 0.15PNA and Shuxuening injection 20mg, every day for 7 days.

Primary Outcome Measures

Name	Time	Method
Perfusion Weighted Imaging	7 days	Reflect the infarction center and low perfusion of tissue

Trial Locations

Locations (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University; 🇨🇳 Beijing, Beijing, China