Coronary Artery Bypass Graft (CABG) surgery Surgery Coronary Artery Bypass Graft (CABG) surgery
Conditions
Interventions
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) Glypro
Sponsors
Neuren Pharmaceuticals Limited (New Zealand)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetics of Glypromate® in patients undergoing CABG surgery to assess dose-response relationships. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
New Zealand
Outcome results
None listed