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| Sponsor: | Brasilia Heart Study Group |
|---|---|
| Information provided by: | Brasilia Heart Study Group |
| ClinicalTrials.gov Identifier: | NCT00905905 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Myocardial Infarction |
Drug: Simvastatin Drug: Ezetimibe-Simvastatin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction |
| Estimated Enrollment: | 40 |
| Study Start Date: | May 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ezetimibe-Simvastatin 10/40 mg |
Drug: Ezetimibe-Simvastatin
Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Other Name: Vytorin
|
| Active Comparator: Simvastatin 40 mg |
Drug: Simvastatin
Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation
Other Names:
|
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil | |
| Hospital de Base do Distrito Federal | |
| Brasilia, DF, Brazil, 70673103 | |
| Study Chair: | Andrei C Sposito, MD, PhD | University of Brasilia Medical School |
More Information
| Responsible Party: | Andrei C. Sposito, University of Brasilia Medical School |
| ClinicalTrials.gov Identifier: | NCT00905905 History of Changes |
| Other Study ID Numbers: | EMI |
| Study First Received: | May 20, 2009 |
| Last Updated: | March 23, 2010 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
myocardial infarction systemic inflammatory activity endothelial function |
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Simvastatin |
Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |