Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01529554
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2012-02-03
Brief Title:
Controlled Level EVERolimus in Acute Coronary Syndromes
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEVER-ACS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None