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

Klingenberg, Roland; Stähli, Barbara E; Heg, Dik; Denegri, Andrea; Manka, Robert; Kapos, Ioannis; von Eckardstein, Arnold; Carballo, David; Hamm, Christian W; Vietheer, Julia; Rolf, Andreas; Landmesser, Ulf; Mach, François; Moccetti, Tiziano; Jung, Christian; Kelm, Malte; Münzel, Thomas; Pedrazzini, Giovanni; Räber, Lorenz; Windecker, Stephan; ... (2022). Controlled-Level EVERolimus in Acute Coronary Syndrome (CLEVER-ACS) - A phase II, randomized, double-blind, multi-center, placebo-controlled trial. American Heart Journal, 247, pp. 33-41. Elsevier 10.1016/j.ahj.2022.01.010

Preview	Text Klingenberg_AmHeartJ_2022_AAM.pdf - Accepted Version Available under License Creative Commons: Attribution-Noncommercial-No Derivative Works (CC-BY-NC-ND). Download (831kB) | Preview
	Text Klingenberg_AmHeartJ_2022.pdf - Published Version Restricted to registered users only Available under License Publisher holds Copyright. Download (1MB)

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.

Interest & Impact

Downloads

175 since deposited on 14 Feb 2022
98 in the past 12 months

Citations

5 Citations in Web of Science ®
6 Citations in Scopus

Search

in Google Scholar™

Services

Actions (login required)

Edit item

Actions (login required)

Edit item