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

Détails

ID Serval
serval:BIB_EF1A03513CD7
Type
Article: article d'un périodique ou d'un magazine.
Sous-type
Synthèse (review): revue aussi complète que possible des connaissances sur un sujet, rédigée à partir de l'analyse exhaustive des travaux publiés.
Collection
Publications
Titre
Design of the randomized, placebo-controlled evolocumab for early reduction of LDL-cholesterol levels in patients with acute coronary syndromes (EVOPACS) trial.
Périodique
Clinical cardiology
Auteur(s)
Koskinas K.C., Windecker S., Buhayer A., Gencer B., Pedrazzini G., Mueller C., Cook S., Muller O., Matter C.M., Räber L., Heg D., Mach F.
Collaborateur(s)
EVOPACS Investigators
ISSN
1932-8737 (Electronic)
ISSN-L
0160-9289
Statut éditorial
Publié
Date de publication
12/2018
Peer-reviewed
Oui
Volume
41
Numéro
12
Pages
1513-1520
Langue
anglais
Notes
Publication types: Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Résumé
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.
Mots-clé
Acute Coronary Syndrome/blood, Acute Coronary Syndrome/drug therapy, Acute Coronary Syndrome/etiology, Antibodies, Monoclonal/administration & dosage, Anticholesteremic Agents/administration & dosage, Biomarkers/blood, Cholesterol, LDL/blood, Cholesterol, LDL/drug effects, Dose-Response Relationship, Drug, Double-Blind Method, Feasibility Studies, Female, Follow-Up Studies, Humans, Hypercholesterolemia/blood, Hypercholesterolemia/complications, Hypercholesterolemia/drug therapy, Male, Middle Aged, Prospective Studies, Time Factors, Treatment Outcome, PCSK9 inhibitor, acute coronary syndrome, lipidology
Pubmed
Web of science
Création de la notice
19/11/2018 14:46
Dernière modification de la notice
20/08/2019 17:16
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