Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Sponsor

Brasilia Heart Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00906451

Collaborator

(none)

Enrollment

Location

Arms

5.9

Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Brachial Artery Endothelial function [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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