Eficacia y seguridad del ácido bempedoico en el síndrome coronario agudo. Diseño del ensayo clínico ES-BempeDACS

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).

Identification number

EudraCT 2021-006550-31.