Sergio Raposeiras-Roubín , Emad Abu-Assi , José Ángel Pérez Rivera , Pablo Jorge Pérez , Ana Ayesta López , Ana Viana Tejedor , Miguel José Corbí Pascual , Anna Carrasquer , César Jiménez Méndez , Cristina González Cambeiro , Aitor Uribarri González , Clara Bonanad Lozano , Marta Marcos Mangas , Ana Merino-Merino , Ester Sánchez-Corral , Isabel Santos-Sánchez , Lara Aguilar-Iglesias , Alberto Alen , José Rozado Castaño , Ester Mínguez de la Guía , Albert Ariza-Solé
{"title":"Efficacy and safety of bempedoic acid in acute coronary syndrome. Design of the clinical trial ES-BempeDACS","authors":"Sergio Raposeiras-Roubín , Emad Abu-Assi , José Ángel Pérez Rivera , Pablo Jorge Pérez , Ana Ayesta López , Ana Viana Tejedor , Miguel José Corbí Pascual , Anna Carrasquer , César Jiménez Méndez , Cristina González Cambeiro , Aitor Uribarri González , Clara Bonanad Lozano , Marta Marcos Mangas , Ana Merino-Merino , Ester Sánchez-Corral , Isabel Santos-Sánchez , Lara Aguilar-Iglesias , Alberto Alen , José Rozado Castaño , Ester Mínguez de la Guía , Albert Ariza-Solé","doi":"10.1016/j.rec.2024.05.017","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction and objectives</h3><div>Only about 1 out of every 3 patients with acute myocardial infarction (AMI) achieve low-density lipoprotein cholesterol (LDL-<span>C</span>) values <<!--> <!-->55<!--> <!-->mg/dL in the first year. The present study aims to evaluate the impact of early intensive therapy on lipid control after an AMI.</div></div><div><h3>Methods</h3><div>An independent, prospective, pragmatic, controlled, randomized, open-label, evaluator-blinded clinical trial (PROBE design) will analyze the efficacy and safety of an oral lipid-lowering triple therapy: high-potency statin<!--> <!-->+<!--> <!-->bempedoic acid (BA) 180<!--> <!-->mg<!--> <!-->+<!--> <!-->ezetimibe (EZ) 10<!--> <!-->mg versus current European-based guidelines (high-potency statin<!--> <!-->±<!--> <!-->EZ 10<!--> <!-->mg), in AMI patients. LDL-C will be determined within the first 48<!--> <!-->hours. Patients with LDL-C ≥ 115<!--> <!-->mg/dL (without previous statin therapy), ≥ 100<!--> <!-->mg/dL (with previous low-potency or high-potency statin therapy at submaximal dose), or ≥ 70<!--> <!-->mg/dL (with previous high-potency statin therapy at high dose) will be randomly assigned 1:1 between 24 and 72<!--> <!-->hours post-AMI to the BA/EZ combination or to statin<!--> <!-->±<!--> <!-->EZ, without BA. The primary endpoint is the proportion of patients reaching LDL-C <<!--> <!-->55<!--> <!-->mg/dL at 8 weeks after treatment.</div></div><div><h3>Results</h3><div>The results of this study will provide novel information for post-AMI LDL-C control by evaluating the usefulness of an early intensive lipid-lowering strategy based on triple oral therapy.</div></div><div><h3>Conclusions</h3><div>Early intensive lipid-lowering triple oral therapy vs the treatment recommended by current clinical practice guidelines could facilitate the achievement of optimal LDL-C levels in the first 2 months after AMI (a high-risk period).</div></div><div><h3>Identification number</h3><div>EudraCT 2021-006550-31.</div></div>","PeriodicalId":38430,"journal":{"name":"Revista española de cardiología (English ed.)","volume":"78 1","pages":"Pages 56-63"},"PeriodicalIF":4.9000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Revista española de cardiología (English ed.)","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1885585724002366","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
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Abstract
Introduction and objectives
Only about 1 out of every 3 patients with acute myocardial infarction (AMI) achieve low-density lipoprotein cholesterol (LDL-C) values < 55 mg/dL in the first year. The present study aims to evaluate the impact of early intensive therapy on lipid control after an AMI.
Methods
An independent, prospective, pragmatic, controlled, randomized, open-label, evaluator-blinded clinical trial (PROBE design) will analyze the efficacy and safety of an oral lipid-lowering triple therapy: high-potency statin + bempedoic acid (BA) 180 mg + ezetimibe (EZ) 10 mg versus current European-based guidelines (high-potency statin ± EZ 10 mg), in AMI patients. LDL-C will be determined within the first 48 hours. Patients with LDL-C ≥ 115 mg/dL (without previous statin therapy), ≥ 100 mg/dL (with previous low-potency or high-potency statin therapy at submaximal dose), or ≥ 70 mg/dL (with previous high-potency statin therapy at high dose) will be randomly assigned 1:1 between 24 and 72 hours post-AMI to the BA/EZ combination or to statin ± EZ, without BA. The primary endpoint is the proportion of patients reaching LDL-C < 55 mg/dL at 8 weeks after treatment.
Results
The results of this study will provide novel information for post-AMI LDL-C control by evaluating the usefulness of an early intensive lipid-lowering strategy based on triple oral therapy.
Conclusions
Early intensive lipid-lowering triple oral therapy vs the treatment recommended by current clinical practice guidelines could facilitate the achievement of optimal LDL-C levels in the first 2 months after AMI (a high-risk period).
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