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Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

This study has been completed.
Information provided by:
Brasilia Heart Study Group Identifier:
First received: May 20, 2009
Last updated: March 23, 2010
Last verified: March 2010
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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Prevention
Official Title: Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by Brasilia Heart Study Group:

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

Secondary Outcome Measures:
  • Endothelial function 30 days after myocardial infarction [ Time Frame: 30th day ]
  • 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

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:
  • Statin
  • Zocor


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

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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Please refer to this study by its identifier: NCT00905905

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

Responsible Party: Andrei C. Sposito, University of Brasilia Medical School Identifier: NCT00905905     History of Changes
Other Study ID Numbers: EMI
Study First Received: May 20, 2009
Last Updated: March 23, 2010

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

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ezetimibe, Simvastatin Drug Combination
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on June 23, 2017