Early escalation of oral lipid-lowering therapy to achieve LDL-cholesterol targets in patients after myocardial infarction: study protocol for the prospective, open-label HAnnover ChOlesterol Lowering in Acute Coronary Syndrome trial.

BACKGROUND

Contemporary registry data indicate that only 20%-25% of patients following acute myocardial infarction achieve guideline-recommended low-density lipoprotein cholesterol (LDL-C) values <1.4 mmol/L (55 mg/dL). The present study aims to evaluate the impact of early intensive therapy (potent statin + ezetimibe ± bempedoic acid) on lipid control after myocardial infarction.

METHODS

This is a prospective, interventional, single-center study designed to assess the effectiveness of bempedoic acid in achieving LDL-C targets in patients following ST-elevation or non-ST-elevation myocardial infarction who remain insufficiently treated with atorvastatin plus ezetimibe. Patients not previously treated with lipid-lowering agents and presenting with admission LDL-C > 2.6 mmol/L (100 mg/dL) will be treated with atorvastatin (at least 40 mg/day or equivalent) plus ezetimibe (10 mg/day) for 6 weeks. Thereafter, the subgroup of patients failing to reach an LDL-C < 1.4 mmol/L (55 mg/dL) will be escalated to additive bempedoic acid (180 mg/day) for another 8 weeks. Those who reach the target will continue the aforementioned therapy. The primary endpoint is the proportion of patients who successfully achieve an LDL-C < 1.4 mmol/L (55 mg/dL) after 8 weeks of treatment with triple therapy. Secondary endpoints include the proportion of patients successfully reaching the target in the overall population and in the background medication group alone.

DISCUSSION: The results of this study will provide novel insights into post-infarction LDL-C control by evaluating the usefulness of an early intensive escalation oral lipid-lowering treatment strategy. Early intensive lipid-lowering triple oral therapy may facilitate the achievement of guideline-recommended LDL-C levels within the first 3 months after myocardial infarction compared with current clinical practice.

CLINICAL TRIAL REGISTRATION: EudraCT 2022-003526-50.