Controlled Level EVERolimus in Acute Coronary Syndromes
Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Acute myocardial infarction (AMI) constitutes the major cause of death in most nations and
death rates and morbidity remain substantial in the years thereafter. Inflammation is a
hallmark throughout the distinct stages of atherosclerotic lesion formation preceding AMI as
well as at the time of plaque rupture and during the post-infarct repair phase. Harnessing
its harmful consequences constitutes an attractive therapeutic approach to address this unmet
medical need.
The objectives of this study are to evaluate the effects of mTOR inhibition (everolimus) on
infarct size, myocardial function and inflammation in patients with ST-Elevation Myocardial
Infarction.
The efficacy objectives are:
1. (1° endpoint):
To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as
change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days
follow-up measured by MRI (Late Gadolinium Enhancement (LGE) for transmurality).
2. (2° endpoint):
To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after
percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.
3. (3° endpoints):
1. Change of left ventricular volume from baseline (12-72 hours after percutaneous
coronary intervention) to 30 days follow-up measured by MRI.
2. Change of biomarkers from time of coronary angiography to 30 days follow-up
including a time-course (AUC). Biomarkers comprise hs-TnT, NT-proBNP, hs-CRP, IL-6
and inflammatory biomarkers OPG, sRANKL, OPN and CCN1.
The safety objectives are:
To explore the effect of mTOR inhibition (everolimus) on several clinical and safety
laboratory parameters including plasma lipid levels and blood count. This will be
complemented by analysis of inflammatory cell subsets in coronary thrombi and peripheral
blood (CD4+ T helper lymphocyte subsets, monocyte subsets).