drugset / Trial / NCT00905905

Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

NCT00905905

Phase 4 Completed 40 enrolled Brasilia Heart Study Group
Non-randomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2009-05
Primary completion
2009-12
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezetimibe Unknown 10 mg
Comparator Simvastatin Small molecule 20 mg

Indications