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Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00905905
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
Brasilia Heart Study Group

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Simvastatin Drug: Ezetimibe-Simvastatin Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction
Study Start Date : May 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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:
  • Statin
  • Zocor



Primary Outcome Measures :
  1. C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction [ Time Frame: 5th day ]

Secondary Outcome Measures :
  1. Endothelial function 30 days after myocardial infarction [ Time Frame: 30th day ]
  2. Stress Insulin Resistance [ Time Frame: 5th day ]
    Evaluation of the change in plasma glucose, insulin and C-peptide from admission to the fifth day after myocardial infarction



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 24 hours after the onset of myocardial infarction symptoms
  • ST-segment elevation of a least 1 mm (frontal plane) or 2 mm (horizontal plane) in two contiguous leads
  • myocardial necrosis, as evidenced by increased CK-MB and troponin levels

Exclusion Criteria:

  • use of statins for the last 6 months before myocardial infarction

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905905


Locations
Brazil
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70673103
Sponsors and Collaborators
Brasilia Heart Study Group
Investigators
Study Chair: Andrei C Sposito, MD, PhD University of Brasilia Medical School

Responsible Party: Andrei C. Sposito, University of Brasilia Medical School
ClinicalTrials.gov Identifier: NCT00905905     History of Changes
Other Study ID Numbers: EMI
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

Keywords provided by Brasilia Heart Study Group:
myocardial infarction
systemic inflammatory activity
endothelial function

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Simvastatin
Ezetimibe
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors