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Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00906451
First Posted: May 21, 2009
Last Update Posted: June 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brasilia Heart Study Group
  Purpose
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 Intervention Phase
Myocardial Infarction Inflammation Endothelial Dysfunction Drug: Simvastatin Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brasilia Heart Study Group:

Primary Outcome Measures:
  • 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:
  • Brachial Artery Endothelial function [ Time Frame: 30 days ]

Enrollment: 58
Study Start Date: November 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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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
  Contacts and Locations
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
  More Information

Publications:
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 Submitted: May 19, 2009
First Posted: May 21, 2009
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