Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000168358
Ethics application status
Approved
Date submitted
2/04/2008
Date registered
7/04/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
SNUG-2: Studying Neurons Using Glypromate® - Second Study
Scientific title
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.
Secondary ID [1] 536 0
Nil
Universal Trial Number (UTN)
Trial acronym
SNUG-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 2987 0
Condition category
Condition code
Cardiovascular 3137 3137 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 2727 0
Treatment: Drugs
Comparator / control treatment
An identical-appearing continuous 4-hour intravenous infusion of sodium chloride 0.9% for injection.
Control group
Placebo

Outcomes
Primary outcome [1] 4021 0
The reduction in cognitive decline using the composite of the 5 domain Z scores.
Timepoint [1] 4021 0
Baseline (pre-surgery), 4-6 weeks and 12-14 weeks post surgery.
Primary outcome [2] 4033 0
The differences in the composite scores from The Activities of Daily Living (ADL) questionnaires
Timepoint [2] 4033 0
Baseline (pre-surgery), 4-6 weeks and 12-14 weeks post surgery.
Secondary outcome [1] 6771 0
Global evaluation of the patient's ability to perform activities of daily living (question 101 from the OARS Multidimensional Functional Questionnaire).
Timepoint [1] 6771 0
Secondary outcome measures are assesses at baseline (pre-surgery), 4-6 and 12-14 weeks post surgery.
Secondary outcome [2] 6772 0
the incidence of stroke and Transient ischaemic Attack (TIA) after CPB surgery.
Timepoint [2] 6772 0
Secondary outcome measures are assessed at baseline (pre-surgery), Day 2, 4-6 weeks and 12-14 weeks post surgery.
Secondary outcome [3] 6773 0
The change in cognitive domain ( power of attention, continuity of attention, quality of workinf memory, quality of episodic memory, speed of memory) and individual cognitive test performance.
Timepoint [3] 6773 0
Secondary outcome measures are assessed at baseline (pre-surgery), 4-6 weeks and 12-14 weeks post surgery.
Secondary outcome [4] 6774 0
A change in the 2 ADL domains will be compared between Glypromate? and placebo
Timepoint [4] 6774 0
Assessed at 4-6 and 12-14 weeks post surgery
Secondary outcome [5] 6775 0
The change in mood from baseline will be compared in the Glypromate? versus placebo groups
Timepoint [5] 6775 0
Assessed at 4-6 and 12-14 weeks post surgery.

Eligibility
Key inclusion criteria
1. Scheduled for non-emergency CABG surgery and/or valve replacement/repair, with CBP
2. Willing to provide written informed consent
3. 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
4. Greater than or equal to 50 years old
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Pre-operative mechanical assist device or intra-aortic balloon pump inserted for shock or low output syndrome
2. Women of child-bearing potential or breastfeeding women
3. 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
4. Congenital heart disease with a risk of polycythaemia, circulatory problems, or need for a shunt
5. Renal insufficiency
6. Past or present bleeding disorder
7. History of organic brain syndrome
8. Currently receiving treatment for alcohol or drug abuse
9. Currently participating in another investigational drug or device study
10. Prior enrolment in this study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation is managed by a central randomisation service operating 24 hours a day , 7 days a week using a web based randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by site using a permuted block technique.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
355
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 627 0
5042
Recruitment postcode(s) [2] 628 0
3065
Recruitment postcode(s) [3] 629 0
6000
Recruitment postcode(s) [4] 630 0
2031
Recruitment postcode(s) [5] 631 0
4102
Recruitment postcode(s) [6] 632 0
5035
Recruitment postcode(s) [7] 633 0
2170
Recruitment postcode(s) [8] 634 0
2050
Recruitment postcode(s) [9] 635 0
2010
Recruitment postcode(s) [10] 809 0
3004
Recruitment postcode(s) [11] 810 0
6009
Recruitment outside Australia
Country [1] 853 0
New Zealand
State/province [1] 853 0
Country [2] 854 0
United States of America
State/province [2] 854 0

Funding & Sponsors
Funding source category [1] 3253 0
Commercial sector/Industry
Name [1] 3253 0
Neuren Pharmaceuticals Ltd
Country [1] 3253 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Neuren Pharmaceuticals Ltd
Address
Level 1
103 Carlton Gore Road
Newmarket Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 2908 0
None
Name [1] 2908 0
Address [1] 2908 0
Country [1] 2908 0

Ethics approval
Ethics application status
Approved

Summary
Brief 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).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28483 0
Address 28483 0
Country 28483 0
Phone 28483 0
Fax 28483 0
Email 28483 0
Contact person for public queries
Name 11640 0
Caroline Thomas
Address 11640 0
Cardiology Research
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 11640 0
Australia
Phone 11640 0
+61 8 82044440
Fax 11640 0
+61 08 82045000
Email 11640 0
c.thomas@flinders.edu.au
Contact person for scientific queries
Name 2568 0
Associate Professor John Knight
Address 2568 0
Flinders Medical Centre
1 Flinders Drive
Bedford Park SA 5042
Country 2568 0
Australia
Phone 2568 0
+61 8 82045618
Fax 2568 0
+61 8 84042019
Email 2568 0
john.knight@flinders.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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