Aernoud Fiolet

218 Chapter 8 METHODS Study Population LoDoCo2was a randomized, controlled, double-blind trial that evaluated colchicine 0.5mg given orally once daily compared to matching placebo for the prevention of cardiovascular events. Initiated in 2014 and completed in 2020, LoDoCo2 enrolled 5,522 patients with chronic coronary artery disease from 43 clinical sites in Australia and the Netherlands, with a median follow-up of 28.6 months. Patients were required to have been in a clinically stable condition for at least six months before enrollment. The study excluded patients with moderate to severe renal impairment (serum creatinine <150 µmol/l or eGFR <50 mL/min/1.73m²), severe heart failure or known intolerance to colchicine. The full list of the in- and exclusion criteria was published in the trial design paper. 12 The primary results of the trial have been published. 11 Prior ACS was defined as either a myocardial infarction, consistent with the definition at the time, or accelerating angina leading to urgent revascularization, and was investigator-reported based on a review of medical charts.The trial protocol was approved by a centralized institutional review board in each participating country (MEC-U, Nieuwegein, the Netherlands and Sir Charles Gairdner Group HREC, Perth, Australia), and the trial was overseen by an independent data and safety monitoring board. All participants provided written informed consent. End points The primary efficacy end point was the composite of cardiovascular death, spontaneous myocardial infarction, ischemic stroke, or ischemia-driven revascularization. All potential events were adjudicated by a clinical events committee, which was blinded to treatment allocation. Statistical Analysis Baseline characteristics for the randomized population, according to the subgroups no prior ACS, recent ACS (six to twenty-four months at randomization), remote ACS (two to seven years at randomization), and very remote ACS (more than seven years at randomization), were summarized using mean and standard deviation for quantitative data and as proportions for categorical data. Patient characteristics were compared by prior ACS status using χ 2 or one-way analysis of variance tests where applicable.