Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

NCT00905905 | Completed Phase 4

• 1 other identifier: EMI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

myocardial infarction; systemic inflammatory activity; endothelial function

Outcome Measures

Primary Outcomes (1)

• C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction

  5th day

Secondary Outcomes (2)

• Endothelial function 30 days after myocardial infarction

  30th day

• Stress Insulin Resistance

  5th day

Study Arms (2)

Ezetimibe-Simvastatin 10/40 mg

EXPERIMENTAL

Drug: Ezetimibe-Simvastatin

Simvastatin 40 mg

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Simvastatin DRUG

Simvastatin 40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation

Also known as: Statin, Zocor

Simvastatin 40 mg

Ezetimibe-Simvastatin DRUG

Ezetimibe-Simvastatin 10-40 mg/day during the first 7 days and then 20 mg/day for 3 more weeks until the evaluation of flow-mediated brachial artery dilation

Also known as: Vytorin

Ezetimibe-Simvastatin 10/40 mg

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• use of statins for the last 6 months before myocardial infarction

Sponsors & Collaborators

• Brasilia Heart Study Group: lead

Study Sites (1)

Hospital de Base do Distrito Federal

Brasília, Federal District, 70673103, Brazil

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Simvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Ezetimibe, Simvastatin Drug Combination

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Ezetimibe; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Andrei C Sposito, MD, PhD

  University of Brasilia Medical School

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 24, 2010

Record last verified: 2010-03

Locations

BR (1)