Condition category
Surgery
Date applied
19/09/2005
Date assigned
09/01/2006
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.neurenpharma.com

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

Publication citations

Additional files

Editorial Notes