Controlled Level EVERolimus in Acute Coronary Syndromes (CLEVER-ACS)
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|ClinicalTrials.gov Identifier: NCT01529554|
Recruitment Status : Recruiting
First Posted : February 9, 2012
Last Update Posted : February 6, 2018
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:
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).
To evaluate microvascular obstruction (MVO) as change from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up evaluated by MRI.
- Change of left ventricular volume from baseline (12-72 hours after percutaneous coronary intervention) to 30 days follow-up measured by MRI.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndromes||Drug: Everolimus Drug: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase I-II Randomized Prospective Double-blind Multi-center Trial on the Effects of a Short Course of Oral Everolimus on Infarct Size, Left Ventricular Remodeling and Inflammation in Patients With Acute ST-Elevation Myocardial Infarction|
|Actual Study Start Date :||January 8, 2015|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Everolimus
Everolimus p.o. for 5 days (d0=7.5 mg, d1=7.5 mg, d2=7.5 mg, d3=5 mg, d4=5mg)
(d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)
Placebo Comparator: Placebo
Placebo comparator with identical composition of tablets except everolimus
matched placebo tablets manufactured to be identical to verum tablets except content of everolimus
- Myocardial infarct size measured by MRI [ Time Frame: Change from baseline at 30 days ]To assess the effect of mTOR inhibition (everolimus) on myocardial infarct size as measured by MRI (Late Gadolinium Enhancement (LGE) for infarct size (transmurality) at 12-72 h (baseline) and 30 days
- Microvascular obstruction (MVO) measured by MRI [ Time Frame: Change from baseline at 30 days ]To evaluate microvascular obstruction (MVO) by MRI at 12-72 h (baseline) and 30 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529554
|Contact: Andrea Denegri, MD||0041 44 255 ext firstname.lastname@example.org|
|University Hospital Bern||Recruiting|
|Contact: Stephan Windecker, Professor email@example.com|
|Principal Investigator: Stephan Windecker, Professor|
|University Hospital Geneva||Recruiting|
|Contact: Francois Mach, Professor firstname.lastname@example.org|
|Principal Investigator: Francois Mach, Professor|
|Contact: Tiziano Moccetti, Professor|
|Principal Investigator: Tiziano Moccetti, Professor|
|University Hospital Zurich||Recruiting|
|Contact: Andrea Denegri, MD +41 44 255 ext 99 78 email@example.com|
|Principal Investigator: Andrea Denegri, MD|
|Study Director:||Thomas F Luescher, Professor||University of Zurich|