- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00905905
Additive Effect of Ezetimibe Upon Simvastatin During Myocardial Infarction
March 23, 2010 updated by: Brasilia Heart Study Group
Additive Effect of Ezetimibe Upon Simvastatin Treatment on Systemic Inflammatory Activity and Endothelial Function During Myocardial Infarction
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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DF
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Brasilia, DF, Brazil, 70673103
- Hospital de Base do Distrito Federal
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ezetimibe-Simvastatin 10/40 mg
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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
Other Names:
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Active Comparator: Simvastatin 40 mg
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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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C- reactive Protein (CRP) elevation during the first 7 days after myocardial infarction
Time Frame: 5th day
|
5th day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Endothelial function 30 days after myocardial infarction
Time Frame: 30th day
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30th day
|
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Stress Insulin Resistance
Time Frame: 5th day
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Evaluation of the change in plasma glucose, insulin and C-peptide from admission to the fifth day after myocardial infarction
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5th day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Andrei C Sposito, MD, PhD, University of Brasilia Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
May 20, 2009
First Submitted That Met QC Criteria
May 20, 2009
First Posted (Estimate)
May 21, 2009
Study Record Updates
Last Update Posted (Estimate)
March 24, 2010
Last Update Submitted That Met QC Criteria
March 23, 2010
Last Verified
March 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
- Ezetimibe
- Ezetimibe, Simvastatin Drug Combination
Other Study ID Numbers
- EMI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Organon and CoCompleted
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Hue University of Medicine and PharmacyUniversità degli Studi di SassariUnknownChronic Kidney Diseases | HypercholesterolemiaVietnam
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Organon and CoCompleted
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University of CologneMerck Sharp & Dohme LLCCompleted
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