Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction
Phase 4 Study of the Effect of Simvastatin Treatment on Inflammatory Response and Endothelial Function After Myocardial Infarction
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 19, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedJune 23, 2011
May 1, 2009
6 months
May 19, 2009
June 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Elevation of plasma C reactive protein
Changes in CRP levels between the first and fifth day after myocardial infarction
Five days
Secondary Outcomes (1)
Brachial Artery Endothelial function
30 days
Study Arms (4)
No lipid-lowering
NO INTERVENTIONNo lipid-lowering treatment during the first 7 days and then simvastatin 20 mg/day for three additional weeks, till the endothelial function assessment
Simvastatin 20 mg
EXPERIMENTALSimvastatin 20 mg/day for 30 days, till the endothelial function assessment
Simvastatin 40 mg
EXPERIMENTALSimvastatin 40 mg/day for 7 days and then switched to simvastatin 20mg/day for additional 3 weeks, till the endothelial function assessment
Simvastatin 80 mg
EXPERIMENTALSimvastatin 80 mg/day for 7 days and then switched to simvastatin 20 mg/day for additional 3 weeks, till the endothelial function assessment
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of statins for at least 6 months prior the myocardial infarction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital de Base do Distrito Federal
Brasília, Federal District, 70000000, Brazil
Related Publications (1)
Sposito AC, Santos SN, de Faria EC, Abdalla DS, da Silva LP, Soares AA, Japiassu AV, Quinaglia e Silva JC, Ramires JA, Coelho OR. Timing and dose of statin therapy define its impact on inflammatory and endothelial responses during myocardial infarction. Arterioscler Thromb Vasc Biol. 2011 May;31(5):1240-6. doi: 10.1161/ATVBAHA.110.218685. Epub 2011 Mar 3.
PMID: 21372302RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrei C Sposito, MD, PhD
University of Brasilia Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 19, 2009
First Posted
May 21, 2009
Study Start
November 1, 2008
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 23, 2011
Record last verified: 2009-05