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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 this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment 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: | Prevention, Non-Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Ezetimibe-Simvastatin 10/40 mg: Experimental |
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
|
| Simvastatin 40 mg: Active Comparator |
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
|
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| Contact: Andrei C Sposito, MD, PhD | 556181394444 | dclandrei@yahoo.com |
| Contact: Jose Carlos Quinaglia e Silva, MD | 556134428439 | quinagliaesilva@yahoo.com.br |
| Brazil, DF | |
| Hospital de Base do Distrito Federal | |
| Brasilia, DF, Brazil, 70673103 | |
More Information
| Responsible Party: | University of Brasilia Medical School ( Andrei C. Sposito ) |
| Study ID Numbers: | EMI |
| Study First Received: | May 20, 2009 |
| Last Updated: | May 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00905905 History of Changes |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
myocardial infarction systemic inflammatory activity endothelial function |
|
Antimetabolites Heart Diseases Molecular Mechanisms of Pharmacological Action Simvastatin Myocardial Ischemia Antilipemic Agents Vascular Diseases Enzyme Inhibitors Ezetimibe Anticholesteremic Agents |
Ischemia Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions Necrosis Pathologic Processes Therapeutic Uses Cardiovascular Diseases Infarction Myocardial Infarction |