Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

Phase 4

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: Ezetimibe-Simvastatin; Drug: Simvastatin

• Registration Number: NCT00905905
• Lead Sponsor: Brasilia Heart Study Group

Brief Summary

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. In fact, the intensity of the inflammatory upregulation is strongly related to the incidence of recurrent coronary events. The investigators previously demonstrated that high dose potent statins can rapidly reduce plasma levels of cholesterol-rich lipoproteins and inflammatory activity in subjects during ACS. In addition, such statin treatment attenuates the post-discharge endothelial dysfunction of these patients. By inference, it is plausible to hypothesize that these beneficial effects during ACS may be intensified by an additive lowering of plasma cholesterol through the treatment with ezetimibe. So far, data is unavailable to verify this assumption. In parallel, data from animal models have suggested that both statins and ezetimibe may reduce insulin sensitivity by their effect on cholesterol content and, by this way, on insulin signaling in liver cells. In this context, the present study aims to investigate the role of the addition of ezetimibe upon statin treatment on stress-induced insulin resistance and on the time-course of the inflammatory response during the acute phase of myocardial infarction and its late effect on endothelium-dependent arterial dilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• Primary Completion: 2009-12
• Study Completion: 2010-01
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-23
• Last Update Posted: 2010-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• less than 24 hours after the onset of myocardial infarction 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 the last 6 months before myocardial infarction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe-Simvastatin 10/40 mg	Ezetimibe-Simvastatin	-
Simvastatin 40 mg	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction	5th day

Secondary Outcome Measures

Name	Time	Method
Endothelial function 30 days after myocardial infarction	30th day
Stress Insulin Resistance	5th day	Evaluation of the change in plasma glucose, insulin and C-peptide from admission to the fifth day after myocardial infarction

Trial Locations

Locations (1)

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