Colchicine for Left Ventricular Infarct Size Reduction in Acute Myocardial Infarction: A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Protocol – The COVERT-MI Study

Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI). They add damage to the myocardium and are associated with clinical adverse events (heart failure cardiovascular death) poor recovery. Colchicine is a well-known alkaloid potent anti-inflammatory properties. In proof-of-concept phase II trial, colchicine has significant 50% reduction infarct size (assessed by creatine kinase levels) comparison placebo acute STEMI patients referred for primary percutaneous coronary intervention (PPCI). The Patients Study (COVERT-MI) an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether short course oral treatment versus decreases presenting PPCI. Adult patients, first episode initial TIMI flow ?1, PPCI, will be randomized (<i>n</i> = 194) 1:1 ratio receive bolus 2 mg followed 0.5 b.i.d. during 5 days or matching placebo. endpoint assessed cardiac magnetic resonance at ± between both groups. main secondary endpoints tested groups hierarchical order left ventricular ejection fraction days, microvascular obstruction presence absolute remodeling 3 months. This academic study being financed grant from French Ministry Health (PHRCN-16-0357). Results this contribute better understanding complex pathophysiology underlying after STEMI. present describes rationale, design, methods trial.