Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

This study has been completed.
Sponsor:
Information provided by:
Brasilia Heart Study Group
ClinicalTrials.gov Identifier:
NCT00906451
First received: May 19, 2009
Last updated: June 21, 2011
Last verified: May 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Changes in CRP levels between the first and fifth day after myocardial infarction


Secondary Outcome Measures:
  • Brachial Artery Endothelial function [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 19, 2009
Last Updated: June 21, 2011
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Infarction
Inflammation
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Simvastatin
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