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Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

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ClinicalTrials.gov Identifier: NCT00906451
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : June 23, 2011
Sponsor:
Information provided by:
Brasilia Heart Study Group

Brief Summary:
During myocardial infarction, inflammatory response may negatively influence ventricle wall remodeling as well as endothelium-dependent vasomotor function in the coronary and systemic arterial systems. Statins have been consistently proved to attenuate inflammation and improve endothelial function. In this study, we tested the effect of different doses of statin on inflammatory response and endothelium-dependent vasodilation.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Inflammation Endothelial Dysfunction Drug: Simvastatin Phase 4

Detailed Description:
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. The intensity of this inflammatory upregulation is strongly related to the incidence of recurrent coronary events. High dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. By inference, it is plausible to hypothesize that these effects during the acute phase of myocardial infarction may influence the post-discharge endothelial dysfunction. So far, data is unavailable to verify this assumption or to define the potency required for such statin anti-inflammatory effect in myocardial infarction patients. The present study aim to investigate the role of statin dose on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 4 Study of the Effect of Simvastatin Treatment on Inflammatory Response and Endothelial Function After Myocardial Infarction
Study Start Date : November 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: No lipid-lowering
No lipid-lowering treatment during the first 7 days and then simvastatin 20 mg/day for three additional weeks, till the endothelial function assessment
Drug: Simvastatin
Simvastatin
Experimental: Simvastatin 20 mg
Simvastatin 20 mg/day for 30 days, till the endothelial function assessment
Drug: Simvastatin
Simvastatin
Experimental: Simvastatin 40 mg
Simvastatin 40 mg/day for 7 days and then switched to simvastatin 20mg/day for additional 3 weeks, till the endothelial function assessment
Drug: Simvastatin
Simvastatin
Experimental: Simvastatin 80 mg
Simvastatin 80 mg/day for 7 days and then switched to simvastatin 20 mg/day for additional 3 weeks, till the endothelial function assessment
Drug: Simvastatin
Simvastatin



Primary Outcome Measures :
  1. Elevation of plasma C reactive protein [ Time Frame: Five days ]
    Changes in CRP levels between the first and fifth day after myocardial infarction


Secondary Outcome Measures :
  1. Brachial Artery Endothelial function [ Time Frame: 30 days ]


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Ages Eligible for Study:   45 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 MI 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 at least 6 months prior the myocardial infarction

Information from the National Library of Medicine

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): NCT00906451


Locations
Brazil
Hospital de Base do Distrito Federal
Brasilia, DF, Brazil, 70000000
Sponsors and Collaborators
Brasilia Heart Study Group
Investigators
Study Chair: Andrei C Sposito, MD, PhD University of Brasilia Medical School

Publications of Results:
Responsible Party: Andrei C. Sposito, University of Brasilia Medical School
ClinicalTrials.gov Identifier: NCT00906451     History of Changes
Other Study ID Numbers: Simvastatin Post-MI
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: May 2009

Keywords provided by Brasilia Heart Study Group:
myocardial infarction
inflammation
endothelial dysfunction

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