Contact information
Type
Scientific
Primary contact
Prof Alan Merry
ORCID ID
Contact details
University of Auckland
Mercy Hospital
98 Mountain Road
Epsom
Auckland
1031
New Zealand
+64 (0)9 623 5700
a.merry@auckland.ac.nz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Neu-GPE-CABG-001
Study information
Scientific title
Acronym
SNUG (Studying Neurons Using Glypromate®)
Study hypothesis
Study is designed:
1. To determine the pharmacokinetics of Glypromate® in patients undergoing Coronary Artery Bypass Graft (CABG) surgery with/without valve replacement/repair
2. To show that Glypromate® use is not associated with major adverse events when compared to placebo in people undergoing CABG surgery
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary Artery Bypass Graft (CABG) surgery
Intervention
This phase two study will be conducted in two stages:
In stage 1 (conducted at the Principal Investigator's site only), patients will be randomised in a 1:1 fashion to receive intravenous (IV) Glypromate® 1 mg/kg/hr for four hours or 3 mg/kg/hr for four hours. Two to four patients are expected to be enrolled into this open-label stage of the study.
In stage 2, participants from five centres will be randomised in a 1:1:1 fashion to receive IV Glypromate® 1 mg/kg/hr for four hours or IV Glypromate® 3 mg/kg/hr over four hours or IV Placebo (normal saline) for four hours. The Glypromate®/Placebo infusion will commence at the start of chest closure.
Participants will be observed from randomisation through to discharge or day 14, whichever comes sooner.
Intervention type
Drug
Phase
Phase II
Drug names
Glypromate®
Primary outcome measures
To determine the pharmacokinetics of Glypromate® in patients undergoing CABG surgery to assess dose-response relationships.
Secondary outcome measures
To monitor the safety profile of Glypromate® treatment compared to placebo in patients undergoing CABG. Data will be collected through to discharge or day 14 whichever comes first.
Overall trial start date
26/09/2005
Overall trial end date
28/02/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Participants must meet all of the following criteria:
1. Be at least 60 years of age
2. Be scheduled for non-urgent, on-pump CABG surgery
3. Be willing to provide written informed consent
4. Be agreeable to be undergo all study tests (collection of blood for PK assessment)
The Glypromate®/placebo infusion will be commenced at the start of chest closure providing the following criteria are met:
1. The patient has been successfully weaned off the bypass pump
2. The patient does not have an Intra-Aortic Balloon Pump (IABP)
3. The anaesthetist has assessed the patient as having no contraindications to receiving Glypromate®/placebo medication
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
30
Participant exclusion criteria
A participant will be ineligible if he/she meets any of the following criteria:
1. Body weight less than 55 kg or more than 120 kg
2. Scheduled to undergo a significant concomitant surgical procedure (e.g. carotid endarterectomy, aortic root repair or replacement, Deep Hypothermic Circulatory Arrest [DHCA] or pulmonary resection)
3. Has a pre or perioperative mechanical assist device or IABP inserted for shock/low output syndrome
4. Renal insufficiency (serum creatinine greater than 0.17 mmol/l) or renal failure requiring dialysis
5. Chronic hepatic failure and/or cirrhosis
6. History of significant haematologic or coagulation disorders, including thrombocytopenia (platelet count less than 50,000), known hypercoagulable state, or recurrent deep vein thrombosis
7. Current participation or participation within the seven days prior to the start of this study in another investigational drug or device study
8. History of or any current condition that in the investigator's opinion would interfere with study participation or evaluation of results
Recruitment start date
26/09/2005
Recruitment end date
28/02/2006
Locations
Countries of recruitment
New Zealand
Trial participating centre
University of Auckland
Auckland
1031
New Zealand
Sponsor information
Organisation
Neuren Pharmaceuticals Limited (New Zealand)
Sponsor details
P.O. Box 9923
Newmarket
Auckland
1031
New Zealand
+64 (0)9 367 7167 ext 89771
mscott@neurenpharma.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Grant from a New Zealand Government Agency, Foundation for Research Science and Technology.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Grant type: Technology for Business Growth
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Grant title: Implementation for Phase II for Glypromate
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Study is also internally funded by Neuren Pharmaceuticals Limited (New Zealand)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary