"The LoDoCo2 Trial":Low Dose Colchicine for secondary prevention of cardiovascular disease.

INTERVENTION: Colchicine 0.5mg tablet taken orally each day for the duration of the trial, It is expected that some participants randomized earlier in the trial will receive treatment for up to 5 years, whereas others randomized later in the trial will likely be on the trial medication for 2 years. In an intention to treat trial, participation continues until the requisite number of primary events have occurred or earlier, should a participant choose to cease the trial medication or the DSMB suggest that the trial be ceased for any other reason Adherence will be determined by questionnaire every 6 months at the time of collection of the new supply of the trial medication, No serum levels of colchicine metabolites are being measured CONDITION: Cardiovascular events [cardiovascular death, ACS including non fatal myocardial infarction and unstable angina, out of hospital cardiac arrest] in patients with proven but stable coronary heart disease Ischemic stroke in patients with proven but stable coronary disease PRIMARY OUTCOME: The time to the first occurrence of the composite of cardiovascular death, non‐fatal acute coronary syndrome or non‐fatal ischemic stroke SECONDARY OUTCOME: other cardiovascular endpoints including new onset atrial fibrillation, deep vein thrombosis, pulmonary embolism as evidenced from the patient record safety measures including rate of intolerance or serious adverse events including rhabdomyolysis as evidenced by the patient records. Rhabdomyolysis determined by acute onset of severe myo‐necrosis evident by marked elevation in serum creatinine kinase Time to first occurrence of either non‐fatal myocardial infarction or unstable angina related to stent disease or graft failure Time to the first occurrence of the composite of sudden cardiac death, non‐fatal out of hospital cardiac arrest, myocardial infarction or unstable angina irrespective of revascularization, or atherosclerotic ischemic stroke (the composite endpoint of the first LoDoCo trial) INCLUSION CRITERIA: Patients with coronary heart disease diagnosed by coronary angiography or CT coronary angiogram who are clinically stable [no cardiovascular related hospital admission in the prior 6 months] and Patients with CABG>10 years ago, unless evidence of graft failure or the need for angioplasty since surgery