Aernoud Fiolet

101 The LoDoCo2 trial rationale, design, and baseline characteristics Table II. Eligibility criteria and exclusions. Eligibility criteria and exclusions Eligibility criteria: 1) Age >35 and ≤82 years. 2) Proven coronary disease; as evidenced by coronary angiography, CT angiography or a Coronary Artery Calcium Score≥ 400 Agatston Units. Individuals with a history of coronary artery bypass surgery are only eligible if they had undergone bypass surgery more than 10 years before or have angiographic evidence of graft failure or have undergone coronary intervention since their bypass surgery. 3) Clinically stable for at least 6 months. Exclusions: 1) Women who are pregnant, breastfeeding or may be considering pregnancy during the study period. 2) Renal impairment: serum creatinine >150 µmol/L or eGFR <50 mL/min. 3) Heart failure – NYHA Class 3 or 4. 4) Valvular heart disease considered likely to require intervention. 5) Dependent or frail or have a life expectancy <5 years. 6) Peripheral neuritis, myositis or marked myo-sensitivity to statins. 7) Already taking long-term colchicine therapy for any other reason. 8) Known intolerance to colchicine. 9) Currently enrolled in a competing trial. Abbreviations: CT, computed tomography; eGFR, estimated glomerular filtration rate; NYHA, New York Heart Association. Run-in phase Eligible patients who provided informed consent received a 30-day open label trial of colchicine 0.5 mg daily. During this time, patients were instructed to take a tablet of colchicine each day in addition to their usual therapy. Randomization phase At the end of the run-in phase, patients who were tolerant to colchicine, had remained clinically stable and willing to continue in the study, were randomized to receive colchicine 0.5 mg once daily or matching placebo. Because short-term exposure to therapy was considered unlikely to affect long-term clinical outcomes, there was no prescribed wash out period between the 30-day open label period and randomization.