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Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial

Authors :
Roland Klingenberg
Barbara E. Stähli
Dik Heg
Andrea Denegri
Robert Manka
Ioannis Kapos
Arnold von Eckardstein
David Carballo
Christian W. Hamm
Julia Vietheer
Andreas Rolf
Ulf Landmesser
François Mach
Tiziano Moccetti
Christian Jung
Malte Kelm
Thomas Münzel
Giovanni Pedrazzini
Lorenz Räber
Stephan Windecker
Christian M. Matter
Frank Ruschitzka
Thomas F. Lüscher
University of Zurich
Publication Year :
2022

Abstract

BACKGROUND Activation of inflammatory pathways during acute myocardial infarction contributes to infarct size and left ventricular (LV) remodeling. The present prospective randomized clinical trial was designed to test the efficacy and safety of broad-spectrum anti-inflammatory therapy with a mammalian target of rapamycin (mTOR) inhibitor to reduce infarct size. DESIGN Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS, clinicaltrials.gov NCT01529554) is a phase II randomized, double-blind, multi-center, placebo-controlled trial on the effects of a 5-day course of oral everolimus on infarct size, LV remodeling, and inflammation in patients with acute ST-elevation myocardial infarction (STEMI). Within 5 days of successful primary percutaneous coronary intervention (pPCI), patients are randomly assigned to everolimus (first 3 days: 7.5 mg qd; days 4 and 5: 5.0 mg qd) or placebo, respectively. The primary efficacy outcome is the change from baseline (defined as 12 h to 5 days after pPCI) to 30-day follow-up in myocardial infarct size as measured by cardiac magnetic resonance imaging (CMRI). Secondary endpoints comprise corresponding changes in cardiac and inflammatory biomarkers as well as microvascular obstruction and LV volumes assessed by CMRI. Clinical events, laboratory parameters, and blood cell counts are reported as safety endpoints at 30 days. CONCLUSION The CLEVER-ACS trial tests the hypothesis whether mTOR inhibition using everolimus at the time of an acute STEMI affects LV infarct size following successful pPCI.

Details

Language :
English
Database :
OpenAIRE
Accession number :
edsair.doi.dedup.....5005fdf37d3cdc29e8b42961b683ddeb
Full Text :
https://doi.org/10.5167/uzh-215362