Abstract Body (Do not enter title and authors here): Background: The renin-angiotensin-aldosterone system plays a key role in infarct size post myocardial infarction (MI) and development of heart failure. Aldosterone antagonism has been shown to reduce mortality in patients with heart failure with reduced ejection fraction and in patients post MI with overt heart failure and reduced ejection fraction. It is unclear if routine aldosterone antagonism is beneficial post MI
Methods: The CLEAR trial is randomized placebo-controlled factorial design trial of colchicine and spironolactone in patients with acute myocardial infarction. Patients were eligible if they had ST elevation myocardial infarction (STEMI) or large NSTEMI. The results of spironolactone factorial will be presented. The co-primary outcomes for spironolactone are (co-primary 1) total composite events of cardiovascular death or new or worsening heart failure, and (co-primary 2) time-to-first occurrence of the composite of cardiovascular death, recurrent MI, stroke, or new or worsening heart failure. Key secondary outcomes include (1) time-to-first occurrence of the composite of cardiovascular death or new or worsening heart failure, (2) time-to-first occurrence of cardiovascular death, and (3) time-to-first occurrence of the composite of cardiovascular death, new or worsening heart failure or significant ventricular arrhythmia. The CLEAR trial was designed to have 84% power to detect a 31.5% relative risk reduction in co-primary 1 and 80% power to detect a 26% relative risk reduction in co-primary outcome 2. The trial randomized 7062 patients in 104 centres in 14 countries and the mean age was 60.6 years, 18% had diabetes and 9% had prior MI.
Conclusions: The CLEAR trial is the largest trial to examine the impact of spironolactone in acute myocardial infarction. The trial will provide clear and reliable evidence of the effect of routine spironolactone in acute myocardial infarction on clinically important outcomes.