1. Efficacy and safety of bempedoic acid in acute coronary syndrome. Design of the clinical trial ES-BempeDACS.
- Author
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Raposeiras-Roubín S, Abu-Assi E, Pérez Rivera JÁ, Jorge Pérez P, Ayesta López A, Viana Tejedor A, Corbí Pascual MJ, Carrasquer A, Jiménez Méndez C, González Cambeiro C, Uribarri González A, Bonanad Lozano C, Marcos Mangas M, Merino-Merino A, Sánchez-Corral E, Santos-Sánchez I, Aguilar-Iglesias L, Alen A, Rozado Castaño J, Mínguez de la Guía E, López Vázquez M, Salmerón Martínez FM, Avivar Sáez Y, Villar Ruiz A, Panera de la Mano JA, García García MT, Pérez-Asensio A, Bompart D, Zaharia G, and Ariza-Solé A
- Subjects
- Humans, Prospective Studies, Male, Female, Treatment Outcome, Drug Therapy, Combination, Cholesterol, LDL blood, Middle Aged, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Anticholesteremic Agents therapeutic use, Ezetimibe therapeutic use, Aged, Acute Coronary Syndrome drug therapy, Dicarboxylic Acids therapeutic use, Dicarboxylic Acids adverse effects, Fatty Acids therapeutic use
- 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)., Identification Number: EudraCT 2021-006550-31., (Copyright © 2024 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.)
- Published
- 2025
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