Aernoud Fiolet

109 The LoDoCo2 trial rationale, design, and baseline characteristics Table IV. Ongoing clinical trials investigating the effect of colchicine in cardiovascular disease. Principal investigator and location Initiation Acronym &Name Study population Sample size Intervention Outcome Proposed/ mean follow-up Clinical trial identifier Acute coronary syndrome Imazio et al. 63 Italy 2013 COACS Colchicine for Acute Coronary Syndromes Acute coronary syndrome 500 Colchicine 0.5mg/day vs. placebo Overall mortality, new acute coronary syndrome, and ischemic stroke. 24 months NCT01906749 Tardif et al. 55 Canada 2015 COLCOT Colchicine Cardiovascular Outcomes Trial Myocardial infarction 4,500 Colchicine 0.5mg/day vs. placebo Cardiovascular death, resuscitated cardiac arrest, myocardial infarction, stroke, angina pectoris requiring hospitalization 3 – 4 years NCT02551094 Jolly et al. 56 Canada 2018 CLEAR-SYNERGYOASIS-9 Colchicine and Spironolactone in Patients With STEMI / SYNERGY Stent Registry ST – elevated myocardial infarction 4,000 Colchicine 1mg/day and/ or spironolactone 25mg/ day and/or placebo and/ or SYNERGY stent (2x2 factorial design), 4 study arms Cardiovascular death, recurrent myocardial infarction, or stroke in the colchicine comparison 2 years NCT03048825 Cerebrovascular disease Kelly et al. 64 Ireland, Belgium, Spain, Greece 2016 CONVINCE Colchicine for Prevention of Vascular Inflammation in Non- cardio Embolic Stroke Ischemic stroke or high risk transient ischaemic attacks 2,623 Colchicine 0.5mg/day vs. placebo Recurrence of non-fatal ischemic stroke, non-fatal major cardiac event and vascular death 5 years NCT02898610