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Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction

B

Brasilia Heart Study Group

Status and phase

Completed
Phase 4

Conditions

Myocardial Infarction

Treatments

Drug: Simvastatin
Drug: Ezetimibe-Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Ezetimibe-Simvastatin 10/40 mg
Experimental group
Treatment:
Drug: Ezetimibe-Simvastatin
Simvastatin 40 mg
Active Comparator group
Treatment:
Drug: Simvastatin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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