Aernoud Fiolet

294 Chapter 12 In summary, patients were eligible for participation if aged 35 – 82 years, if they had coronary disease proven by either invasive coronary angiography or computed tomography coronary angiographywith anAgatston calcium score ≥ 400 units and if theywere considered clinically stable to the discretion of the caregiver. Exclusion criteria were an estimated glomerular filtration rate (eGFR) < 50 ml/min/1,73m 2 ) or a serum creatinine > 150 µmol/L, severe heart failure defined by a systolic or diastolic New York Heart Association Functional classification III or IV, moderate or severe valvular heart disease considered presumably to require intervention, dependency or vulnerability or an estimated life expectancy of less than 5 years, peripheral neuritis, myositis or noticeable myo-sensitivity to statins, the necessity to take colchicine for any other indication or concomitant drug use of strong Cytochrome P (CYP) 3A4 isoenzme inhibiting drugs (verapamil, azithromycine, clarithromycin). Exposure and outcomes Patients were supplied with colchicine 0.5mg once daily to be taken orally at the same time of the day for 30 consecutive days. Compliance and any perceived side effects were assessed afterwards by interview with dedicated research personnel. For patients considered to be intolerant, a re-challenge was possible after which symptomatology was re-assessed. Al perceived side effects were collected in a routine fashion on pre-specified electronic case reports forms. For the purpose of this study, incompliance was defined as exposure of less than three consecutive days of open label treatment. Intolerance was patient and investigator reported and defined as any unacceptable side effects complicating further participation in the randomized phase of the trial. Clinical data on medical history and drug use were collected routinely during the screening visits. Race was self-reported. Medication use was checked using the actual pharmacy dispense registry. Reporting of glomerular filtration rate was based on last available clinical measurement if available within the last six months or reassessed. Data on ventricular function was retrieved form regular clinical echocardiography if available. Dosage of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) was standardized to the atorvastatin dose equivalent according to the American guidelines for statin therapy. 12