Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Brasilia Heart Study Group
ClinicalTrials.gov Identifier:
NCT00905905
First received: May 20, 2009
Last updated: March 23, 2010
Last verified: March 2010
  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 4

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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function 30 days after myocardial infarction [ Time Frame: 30th day ] [ Designated as safety issue: No ]
  • Stress Insulin Resistance [ Time Frame: 5th day ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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

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
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014