Simvastatin Effect on Inflammation and Endothelial Function After Myocardial Infarction

Brasilia Heart Study Group

Status and phase: Completed; Phase 4

Conditions: Inflammation; Endothelial Dysfunction; Myocardial Infarction

Treatments: Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00906451

Simvastatin Post-MI

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 45 to 70 years old

Volunteers: No 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

Exclusion criteria

• Use of statins for at least 6 months prior the myocardial infarction

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 4 patient groups

No lipid-lowering

No Intervention group

Description:

No lipid-lowering treatment during the first 7 days and then simvastatin 20 mg/day for three additional weeks, till the endothelial function assessment

Treatment:

Drug: Simvastatin

Simvastatin 20 mg

Experimental group

Description:

Simvastatin 20 mg/day for 30 days, till the endothelial function assessment

Treatment:

Drug: Simvastatin

Simvastatin 40 mg

Experimental group

Description:

Simvastatin 40 mg/day for 7 days and then switched to simvastatin 20mg/day for additional 3 weeks, till the endothelial function assessment

Treatment:

Drug: Simvastatin

Simvastatin 80 mg

Experimental group

Description:

Simvastatin 80 mg/day for 7 days and then switched to simvastatin 20 mg/day for additional 3 weeks, till the endothelial function assessment

Treatment:

Drug: Simvastatin