Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction; Inflammation; Endothelial Dysfunction
• Interventions: Drug: Simvastatin

• Registration Number: NCT00906451
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-11
• Status Verified: 2009-05
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No lipid-lowering	Simvastatin	No 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	Simvastatin	Simvastatin 20 mg/day for 30 days, till the endothelial function assessment
Simvastatin 80 mg	Simvastatin	Simvastatin 80 mg/day for 7 days and then switched to simvastatin 20 mg/day for additional 3 weeks, till the endothelial function assessment
Simvastatin 40 mg	Simvastatin	Simvastatin 40 mg/day for 7 days and then switched to simvastatin 20mg/day for additional 3 weeks, till the endothelial function assessment

Primary Outcome Measures

Name	Time	Method
Elevation of plasma C reactive protein	Five days	Changes in CRP levels between the first and fifth day after myocardial infarction

Secondary Outcome Measures

Name	Time	Method
Brachial Artery Endothelial function	30 days

Trial Locations

Locations (1)

Hospital de Base do Distrito Federal; 🇧🇷 Brasilia, DF, Brazil