Viewing Study NCT00905905



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Study NCT ID: NCT00905905
Status: COMPLETED
Last Update Posted: 2010-03-24
First Post: 2009-05-20

Brief Title: Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
Sponsor: Brasilia Heart Study Group
Organization: Brasilia Heart Study Group

Study Overview

Official Title: Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction
Status: COMPLETED
Status Verified Date: 2010-03
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: None
Brief Summary: During acute coronary syndromes ACS the generation of inflammatory mediators negatively influences arterial wall remodeling and the endothelium-dependent vasomotor function in the coronary and systemic arterial systems In fact the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS In addition such statin treatment attenuates the post-discharge endothelial dysfunction of these patients By inference it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe So far data is unavailable to verify this assumption In parallel data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and by this way on insulin signaling in liver cells In this context the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation
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