Aernoud Fiolet

100 Chapter 4 Study design LoDoCo2 is an investigator-initiated randomized, placebo-controlled, double blind trial that includes participants with known stable coronary artery disease who have proven tolerant to colchicine 0.5 mg daily during a 30-day open label run in phase (Figure 4). Participating sites In Australia, participants were recruited from the private practices of members of GenesisCare located across metropolitan Perth and regional centers in Western Australia. In the Netherlands, participants were recruited from 30 hospitals within the network of the Dutch Network for Cardiovascular Research (WCN) that represents most hospitals in the Netherlands. Study procedures Inclusion and exclusion criteria The inclusion and exclusion criteria were similar as those used in the LoDoCo pilot. 30 Accordingly the study includes male and female patients aged between 35–82 years with proven coronary artery disease who have been clinically stable for at least 6 months and do not have advanced heart failure, severe valvular heart disease, advanced renal impairment, known intolerance to colchicine, pre-existing peripheral neuritis, myositis or marked myo-sensitivity to statins and are able to provide informed consent (Table II). A broad age range of participants was mandated to ensure the hypothesis was tested in a cohort representative of those seen in routine practice. The upper age range was set to ensure octogenarians were included in the trial, but truncated at 82 years of age with regard to the reality that those recruited in their early 80s would be in their mid-80s by the end of the trial. Those with advanced heart failure and those with valvular disease likely to require intervention were excluded as we were focused on the effect of therapy of atherosclerosis per se. All participants had objective invasive or non-invasive radiologic evidence of coronary artery disease. Patients with recent successful coronary artery bypass grafting (CABG) without any early post-procedural new coronary re-interventions are generally recognized as being at low risk of CV events and were therefore excluded from the trial.