Rationale and design of a multi‐center,prospective randomized controlled trial on the effects of sacubitril–valsartan versus enalapril on left ventricular remodeling in ST‐elevation myocardial infarction: The PERI‐STEMI study

BackgroundAngiotensin receptor neprilysin inhibitor (ARNI) sacubitril‐valsartan has been recommended as one of the first‐line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST‐segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI‐STEMI trial is to assess whether sacubitril‐valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.HypothesisWe hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6‐month follow‐up.MethodsPERI‐STEMI is an investigator‐initiated, prospective, multi‐center, randomized, open‐label, superiority trial with blinded evaluation of outcomes. A total of 376 first‐time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril‐valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post‐PPCI. The primary endpoint is the change of indexed LV mass at the 6‐month follow‐up CMR.ResultsEnrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.ConclusionsThe results of the PERI‐STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR‐based risk stratification and therapy selection for these patients. PERI‐STEMI is registered at ClinicalTrials.gov ({"type":"clinical-trial","attrs":{"text":"NCT04912167","term_id":"NCT04912167"}}NCT04912167).