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Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
This study is not yet open for participant recruitment.
Verified by Brasilia Heart Study Group, May 2009
First Received: May 20, 2009   No Changes Posted
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

Resource links provided by NLM:


Further study details as provided by Brasilia Heart Study Group:

Primary Outcome Measures:
  • CRP elevation during the first 7 days after myocardial infarction [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Endothelial function 30 days after myocardial infarction [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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
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

Contacts
Contact: Andrei C Sposito, MD, PhD 556181394444 dclandrei@yahoo.com
Contact: Jose Carlos Quinaglia e Silva, MD 556134428439 quinagliaesilva@yahoo.com.br

Locations
Brazil, DF
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70673103
Sponsors and Collaborators
Brasilia Heart Study Group
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010