Efficacy and safety of bempedoic acid in acute coronary syndrome. Design of the clinical trial ES-BempeDACS.

IF 7.2 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
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
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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).

Identification number: EudraCT 2021-006550-31.

贝门冬氨酸对急性冠状动脉综合征的疗效和安全性。临床试验 ES-BempeDACS 的设计。
导言和目标:每 3 名急性心肌梗死(AMI)患者中只有约 1 人达到低密度脂蛋白胆固醇(LDL-C)值 方法:一项独立、前瞻性、实用、对照、随机、开放标签、评估者盲法临床试验(PROBE 设计)将分析口服降脂三联疗法(高能他汀+贝美多克(BA)180 毫克+依折麦布(EZ)10 毫克)与目前欧洲指南(高能他汀 ± EZ 10 毫克)对急性心肌梗死患者的疗效和安全性。低密度脂蛋白胆固醇(LDL-C)将在最初 48 小时内测定。低密度脂蛋白胆固醇≥115毫克/分升(既往未接受过他汀类药物治疗)、≥100毫克/分升(既往接受过低剂量或高剂量他汀类药物治疗)或≥70毫克/分升(既往接受过高剂量他汀类药物治疗)的患者将在急性心肌梗死后24至72小时内按1:1的比例随机分配到BA/EZ组合或他汀类药物±EZ(不含BA)。主要终点是达到 LDL-C 结果的患者比例:这项研究的结果将通过评估基于三联口服疗法的早期强化降脂策略的实用性,为急性心肌梗死后的 LDL-C 控制提供新的信息:结论:早期强化降脂三联口服疗法与现行临床实践指南推荐的疗法相比,有助于在急性心肌梗死后的头 2 个月(高风险期)达到最佳 LDL-C 水平。标识号:EudraCT 2021-006550-31。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.70
自引率
0.00%
发文量
219
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