NCT00166036|CompletedPhase 2Results
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
STOPCAP
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Sponsor study identifier
interventional
36
1 country
1
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2008
Actual (reported)Study Completion
April 2009
Actual (reported)Thirty-six subjects with hyperlipidemia and metabolic syndrome and/or diabetes were randomized in a double-blind manner to either pravastatin 80 mg or atorvastatin 10 mg daily. Oxidative stress (dROMs assay that measures lipid hydroperoxides, plasma thiobarbituric acid reactive substances \[TBARS\], and aminothiol levels) and brachial artery flow-mediated dilation (FMD) were measured at baseline and after 12 weeks of statin therapy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2009
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 14, 2005
Actual (reported)March 2008
Actual (reported)April 2009
Actual (reported)September 8, 2014
Actual (reported)Change in Plasma Thiobarbituric Acid Reactive Substance (TBARS) Levels
Oxidative stress was assessed with plasma thiobarbituric acid reactive substance (TBARS) levels (an index of lipid peroxidation).Oxidative stress reflects an imbalance between the systemic manifestation of reactive oxygen species and a biological system's ability to readily detoxify the reactive intermediates or to repair the resulting damage.We hypothesized that equipotent doses of these two statins will have divergent effects on markers of oxidative stress and endothelial function.
Baseline &12 Weeks
Change in Flow-mediated Dilatation (FMD)
Baseline & 12 Weeks
12 Weeks of Oral Atorvastatin 10 mg therapy.
12 Weeks of Oral Pravastatin 80 mg therapy.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Emory University Hospital
Atlanta, Georgia, 30322, United States
Murrow JR, Sher S, Ali S, Uphoff I, Patel R, Porkert M, Le NA, Jones D, Quyyumi AA. The differential effect of statins on oxidative stress and endothelial function: atorvastatin versus pravastatin. J Clin Lipidol. 2012 Jan-Feb;6(1):42-9. doi: 10.1016/j.jacl.2011.08.006. Epub 2011 Sep 13.
Detection of changes in Oxidative stress with significance requires a much larger cohort study.
Arshed A Quyyumi, MD
Emory University
36 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
September 2004
Date type not reportedThis date has not been verified as actual or estimated.
Evaluate Safety and Efficacy of AEGR-733 and Atorvastatin vs Atorvastatin Monotherapy in Hypercholesterolemia
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Primary Completion
March 2008
Actual (reported)Study Completion
April 2009
Actual (reported)Last Updated
September 8, 2014
Results First Posted
September 8, 2014
Record last verified: 2014-08
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Source: ClinicalTrials.gov.
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