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

NCT02259738 | Completed Phase 2 DMC

• 1 other identifier: hanying1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Infarction

Outcome Measures

Primary Outcomes (1)

• Perfusion Weighted Imaging

  Reflect the infarction center and low perfusion of tissue

  7 days

Study Arms (1)

Human urinary kallidinogenase and Shuxuening injection

EXPERIMENTAL

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

Drug: Human Urinary Kallidinogenase; Drug: Shuxuening injection

Interventions

Human Urinary Kallidinogenase DRUG

Also known as: youruikelin

Human urinary kallidinogenase and Shuxuening injection

Shuxuening injection DRUG

Human urinary kallidinogenase and Shuxuening injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• XuanwuH 2: lead

Study Sites (1)

Department of Neurolgy,Xuanwu Hospital of Capital Medical University

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Cerebral Infarction

Interventions

shuxuening

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: October 8, 2014
• Study Start: January 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

CN (1)