Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
Information source: Brasilia Heart Study Group
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Myocardial Infarction
Intervention: Simvastatin (Drug); Ezetimibe-Simvastatin (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Brasilia Heart Study Group Overall contact:
Andrei C Sposito, MD, PhD, Phone: 556181394444, Email: dclandrei@yahoo.com
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 this context, the present study aims to investigate the role of the addition
of ezetimibe upon statin treatment on the time-course of the inflammatory response during
the acute phase of myocardial infarction and its late effect on endothelium-dependent
arterial dilation.
Clinical Details
Official title: Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction
Study design: Prevention, Non-Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: CRP elevation during the first 7 days after myocardial infarction
Secondary outcome: Endothelial function 30 days after myocardial infarction
Eligibility
Minimum age: 40 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Andrei C Sposito, MD, PhD, Phone: 556181394444, Email: dclandrei@yahoo.com
Hospital de Base do Distrito Federal, Brasilia, DF 70673103, Brazil
Additional Information
Starting date: May 2009
Ending date: August 2009
Last updated: May 20, 2009
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