The CO-POC trial COlchicine for the prevention of Peri-Operative Complications: A prospective randomised placebo controlled, double blinded study to assess the role of colchicine in decreasing myocardial injury during cardiac surgery

AIMS: The aim of the vanguard Co-POC trial is to assess the safety and feasibility of the trial protocol and to obtain important preliminary data on the effect that colchicine 0.5mg once daily for up to 3 days pre-operatively and 30 days post-operatively has on the incidence and extent of post-operative myocardial injury after coronary artery bypass graft (CABG) surgery. DESIGN AND METHODS: The Co-POC vanguard trial is a RCT of colchicine v placebo nested in the Australian VISION Cardiac Surgery cohort. Eligible patients recruited into the VISION Cardiac Surgery study who are undergoing isolated coronary artery bypass graft surgery will be offered the opportunity to participate in the vanguard Co-POC trial. We will recruit 204 patients into this pilot trial (1:1 recruitment). Patients will be randomised to colchicine 0.5mg once daily or matching placebo. Treatment will be commenced 3 days prior to surgery (but can be commenced up to 24 hours pre-operatively if necessary) and will be continued for 1 month after surgery. Medications will be provided by Aspen Pharmacare Australia according to the US Food and Drug Administration current good manufacturing practice regulations. All concomitant medications will be provided at the discretion of treating clinicians and in keeping with clinical guidelines. Patients will have blood samples collected for hs-cTnI <4 hours pre-operatively and post-operatively at 6-12 hours and on days 1 to 3 (in keeping with the VISION Cardiac Surgery protocol). Analysis plan: All analyses will be by intention to treat. Groups will be compared using the Mann-Whitney U and chi-square tests as appropriate. Kaplan Meier curves will be used to demonstrate event free survival and groups compared using the log-rank test.