A randomised, double-blind, placebo-controlled study of Glypromate® in patients undergoing coronary artery bypass graft surgery

ISRCTN	ISRCTN67437862
DOI	https://doi.org/10.1186/ISRCTN67437862
Secondary identifying numbers	Neu-GPE-CABG-001

Submission date: 19/09/2005
Registration date: 09/01/2006
Last edited: 21/09/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alan Merry
Scientific

University of Auckland
Mercy Hospital
98 Mountain Road
Epsom
Auckland
1031
New Zealand

Phone	+64 (0)9 623 5700
Email	a.merry@auckland.ac.nz

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	SNUG (Studying Neurons Using Glypromate®)
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	Glypromate®
Primary outcome measure	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 study start date	26/09/2005
Completion date	28/02/2006

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	30
Key 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
Key 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
Date of first enrolment	26/09/2005
Date of final enrolment	28/02/2006

Locations

Countries of recruitment

New Zealand

Study participating centre

University of Auckland

Auckland
1031
New Zealand

Sponsor information

Neuren Pharmaceuticals Limited (New Zealand)
Industry

P.O. Box 9923
Newmarket
Auckland
1031
New Zealand

Phone	+64 (0)9 367 7167 ext 89771
Email	mscott@neurenpharma.com
Website	http://www.neurenpharma.com
"ROR"	https://ror.org/0503fq502

Funders

Funder type

Industry

Grant from a New Zealand Government Agency, Foundation for Research Science and Technology.

No information available

Grant type: Technology for Business Growth

No information available

Grant title: Implementation for Phase II for Glypromate

No information available

Study is also internally funded by Neuren Pharmaceuticals Limited (New Zealand)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan