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, Macarena López Vázquez, Francisco Manuel Salmerón Martínez, Ylènia Avivar Sáez, Alberto Villar Ruiz, José Antonio Panera de la Mano, Marina Teresa García García, Ana Pérez-Asensio, Daznia Bompart, Georgiana Zaharia, 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, Macarena López Vázquez, Francisco Manuel Salmerón Martínez, Ylènia Avivar Sáez, Alberto Villar Ruiz, José Antonio Panera de la Mano, Marina Teresa García García, Ana Pérez-Asensio, Daznia Bompart, Georgiana Zaharia, Albert Ariza-Solé","doi":"10.1016/j.rec.2024.05.017","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Only about 1 out of every 3 patients with acute myocardial infarction (AMI) achieve low-density lipoprotein cholesterol (LDL-C) values <55mg/dL in the first year. The present study aims to evaluate the impact of early intensive therapy on lipid control after an AMI.</p><p><strong>Methods: </strong>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) 180mg+ezetimibe (EZ) 10mg versus current European-based guidelines (high-potency statin±EZ 10mg), in AMI patients. LDL-C will be determined within the first 48hours. Patients with LDL-C ≥ 115mg/dL (without previous statin therapy), ≥ 100mg/dL (with previous low-potency or high-potency statin therapy at submaximal dose), or ≥ 70mg/dL (with previous high-potency statin therapy at high dose) will be randomly assigned 1:1 between 24 and 72hours post-AMI to the BA/EZ combination or to statin±EZ, without BA. The primary endpoint is the proportion of patients reaching LDL-C <55mg/dL at 8 weeks after treatment.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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).</p><p><strong>Identification number: </strong>EudraCT 2021-006550-31.</p>","PeriodicalId":38430,"journal":{"name":"Revista española de cardiología (English ed.)","volume":" ","pages":""},"PeriodicalIF":7.2000,"publicationDate":"2024-07-24","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://doi.org/10.1016/j.rec.2024.05.017","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
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 <55mg/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) 180mg+ezetimibe (EZ) 10mg versus current European-based guidelines (high-potency statin±EZ 10mg), in AMI patients. LDL-C will be determined within the first 48hours. Patients with LDL-C ≥ 115mg/dL (without previous statin therapy), ≥ 100mg/dL (with previous low-potency or high-potency statin therapy at submaximal dose), or ≥ 70mg/dL (with previous high-potency statin therapy at high dose) will be randomly assigned 1:1 between 24 and 72hours post-AMI to the BA/EZ combination or to statin±EZ, without BA. The primary endpoint is the proportion of patients reaching LDL-C <55mg/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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