医学
心肌梗塞
内科学
心脏病学
安慰剂
临床终点
经皮冠状动脉介入治疗
射血分数
蒂米
心力衰竭
随机对照试验
病理
替代医学
作者
Didier Bresson,François Roubille,Cyril Prieur,Loïc Bière,Fabrice Ivanés,Claire Bouleti,Olivier Dubreuil,Gilles Rioufol,Florent Boutitie,Georges Sideris,Meyer Elbaz,Thomas Bochaton,Charles de Bourguignon,Naoual El Jonhy,Nathalie Dufay,C. Dhelens,Pierre Croisille,Fabrice Prunier,Denis Angoulvant,Michel Ovize,Delphine Maucort‐Boulch,Nathan Mewton
出处
期刊:Cardiology
[S. Karger AG]
日期:2021-01-01
卷期号:146 (2): 151-160
被引量:12
摘要
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 and cardiovascular death) and poor myocardial recovery. Colchicine is a well-known alkaloid with potent anti-inflammatory properties. In a proof-of-concept phase II trial, colchicine has been associated with a significant 50% reduction of infarct size (assessed by creatine kinase levels) in comparison to placebo in acute STEMI patients referred for primary percutaneous coronary intervention (PPCI). The Colchicine in STEMI Patients Study (COVERT-MI) is an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether a short course oral treatment with colchicine versus placebo decreases myocardial injury in patients presenting with STEMI referred for PPCI. Adult patients, with a first STEMI episode and an initial TIMI flow ≤1, referred for PPCI, will be randomized (<i>n</i> = 194) in a 1:1 ratio to receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. treatment during 5 days or matching placebo. The primary endpoint will be the reduction in infarct size as assessed by cardiac magnetic resonance at 5 ± 2 days between both groups. The main secondary endpoints will be tested between groups in hierarchical order with left ventricular ejection fraction at 5 days, microvascular obstruction presence at 5 days, and absolute adverse left ventricular remodeling between 5 days and 3 months. This academic study is being financed by a grant from the French Ministry of Health (PHRCN-16-0357). Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present study describes the rationale, design, and methods of the trial.
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