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ActivePhase 3ACTRN12608000168358

SNUG-2: Studying Neurons Using Glypromate® - Second Study

A Randomised, Double-Blind, Placebo-controlled Study of Glypromate® in Patients Undergoing Cardiopulmonary Bypass Surgery, evaluating the efficacy of Glypromate® compared to placebo in the reduction of cognitive decline and comparative levels in functional activities of daily living in these patients.

Sponsor

Neuren Pharmaceuticals Ltd

Enrollment

355 participants

Start Date

Sep 18, 2007

Study Type

Interventional

Conditions

Cardiopulmonary bypass (CPB) procedures for coronary bypass grafting (CABG) and/or valve replacement/repair due to the significant incidence of neurocognitive changes following such surgery

Summary

The purpose of this research study is to investigate if Glypromate® can reduce changes in brain functioning which may occur following cardiopulmonary bypass (CPB) surgery. Glypromate® is a synthetic (man-made) drug derived from a naturally occuring human protein. Two previous human studies have been performed to look for side effects of the medicine, but this is the first study to see if Glypromate® can limit the changes in brain functioning following open heart surgery. Approximately 672 people from the United States, Australia and New Zealand will participate in this study. Neuropsychological tests (to measure brain functioning), and questionnaires designed to examine normal daily activities, mood and intelligence will be done before and after surgery (at 4-6 weeks and 12-14 weeks).

Eligibility

Sex: Both males and femalesMin Age: 50 Yearss

Inclusion Criteria4

  • Scheduled for non-emergency CABG surgery and/or valve replacement/repair, with CBP
  • Willing to provide written informed consent
  • Able and agreeable to undergo all cognitive and ADL testing ( i.e. understands English, able to read,write, have sufficient motor dexterity and be avilable for follow visits at 4-6 weeks and 12-14 weeks post surgery
  • Greater than or equal to 50 years old

Exclusion Criteria10

  • Pre-operative mechanical assist device or intra-aortic balloon pump inserted for shock or low output syndrome
  • Women of child-bearing potential or breastfeeding women
  • History of or any current condition that in the Investigator's opinion would interfere with study participation or evaluation of results, including atrial myxoma or scheduled for aortic root repair
  • Congenital heart disease with a risk of polycythaemia, circulatory problems, or need for a shunt
  • Renal insufficiency
  • Past or present bleeding disorder
  • History of organic brain syndrome
  • Currently receiving treatment for alcohol or drug abuse
  • Currently participating in another investigational drug or device study
  • Prior enrolment in this study

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Interventions

This is an international, multicentre study of Glypromate® administered at 1mg/kg/hr for 4 hours as a continuous intravenous infusion to patients undergoing CABG surgery and/or valve replacement/repai

This is an international, multicentre study of Glypromate® administered at 1mg/kg/hr for 4 hours as a continuous intravenous infusion to patients undergoing CABG surgery and/or valve replacement/repair with CPB. Eligible patients will be assigned to one of two groups (active treatment or placebo) in a 1:1 ratio. Glypromate® or placebo will be given to the patient at the end of the surgery as this is the time at which the drug is thought to be most effective.

Locations(2)

New Zealand

United States of America

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ACTRN12608000168358