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 |
| Protocol serial number | Neu-GPE-CABG-001 |
| Sponsor | Neuren Pharmaceuticals Limited (New Zealand) |
| Funders | Grant from a New Zealand Government Agency, Foundation for Research Science and Technology., Grant type: Technology for Business Growth, Grant title: Implementation for Phase II for Glypromate, Study is also internally funded by Neuren Pharmaceuticals Limited (New Zealand) |
- 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
Scientific
University of Auckland
Mercy Hospital
98 Mountain Road
Epsom
Auckland
1031
New Zealand
| Phone | +64 (0)9 623 5700 |
|---|---|
| a.merry@auckland.ac.nz |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Glypromate® |
| Primary outcome measure(s) |
To determine the pharmacokinetics of Glypromate® in patients undergoing CABG surgery to assess dose-response relationships. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 28/02/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
1031
New Zealand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
