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Clin Cardiol. 2018 Dec;41(12):1513-1520. doi: 10.1002/clc.23112. Epub 2018 Nov 26.

Design of the randomized, placebo-controlled evolocumab for early reduction of LDL-cholesterol levels in patients with acute coronary syndromes (EVOPACS) trial.

Author information

1
Department of Cardiology, Bern University Hospital, Bern, Switzerland.
2
PRISM Scientific Sàrl, Switzerland.
3
Department of Cardiology, Geneva University Hospital, Geneva, Switzerland.
4
Cardiocentro, Lugano, Switzerland.
5
Department of Cardiology and Cardiovascular Research Institute Basel, University Hospital Basel, Basel, Switzerland.
6
Department of Cardiology, Fribourg Hospital and University, Fribourg, Switzerland.
7
Service of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.
8
Department of Cardiology, University Heart Center, University Hospital Zurich, Zurich, Switzerland.
9
CTU Bern, University of Bern, Bern, Switzerland.

Abstract

Statins lower low-density lipoprotein cholesterol (LDL-C) and improve clinical outcomes in patients with atherosclerotic cardiovascular disease (CVD). Patients with acute coronary syndromes (ACS) often do not achieve LDL-C targets despite potent statin treatment, and have a particularly high risk of early recurrent events. Evolocumab, a proprotein convertase subtilisin/kexin type (PCSK9)-inhibitor resulting in rapid, marked LDL-C reduction, has been studied in hypercholesterolemic subjects without CVD and stabilized patients with CVD; the feasibility, safety, and efficacy of this treatment initiated in the acute phase of ACS remain unknown. We report the design of evolocumab for early reduction of LDL-cholesterol levels in patients with ACS (EVOPACS), a phase-3, multicenter, randomized, double-blind, placebo-controlled trial to assess the feasibility, safety, and LDL-C-lowering efficacy of evolocumab on top of atorvastatin 40 mg in patients with ACS. The primary endpoint is percent change in LDL-C from baseline to 8 weeks. Secondary endpoints are adverse events and serious adverse events. Against a background of beneficial cardiovascular effects of statins beyond LDL-C lowering and in view of preclinical evidence of similar effects of PCSK9 inhibition, the study will also address a variety of exploratory endpoints including the change in C-reactive protein and other inflammatory biomarkers; platelet reactivity; and occurrence of contrast-induced acute kidney injury and myocardial injury in patients undergoing cardiac catheterization. An intracoronary imaging sub-study will investigate the change from baseline in the lipid core burden index in non-culprit lesions, as assessed by serial near-infrared spectroscopy. Recruitment began in January 2018 and enrollment of 308 patients is planned.

KEYWORDS:

PCSK9 inhibitor; acute coronary syndrome; lipidology

PMID:
30421481
DOI:
10.1002/clc.23112
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