A randomised, double-blind, placebo-controlled study of Glypromate® in patients undergoing coronary artery bypass graft 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. CONDITION: Coronary Artery Bypass Graft (CABG) surgery ; Surgery ; Coronary Artery Bypass Graft (CABG) surgery PRIMARY OUTCOME: To determine the pharmacokinetics of Glypromate® in patients undergoing CABG surgery to assess dose‐response relationships. SECONDARY OUTCOME: 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. 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