Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166036
Status:
COMPLETED
Last Update Posted:
2014-09-08
First Post:
2005-09-12
Brief Title:
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells Comparison of Atorvastatin With Pravastatin
Status:
COMPLETED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STOPCAP
Brief Summary:
Thirty-six subjects with hyperlipidemia and metabolic syndrome andor 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
Detailed Description:
Individuals with a high cholesterol level diabetes or metabolic syndrome collection of abnormalities such as high blood pressure high triglyceride levels fat obesity high blood glucose level have an increased risk of developing a hardening of the arteries and heart disease
A group of medications called statins commonly used worldwide to lower cholesterol levels are known to reduce the risk of heart disease through their effects on reducing cholesterol levels These medications also have effects beyond the lowering of cholesterol that may help mediate their beneficial effects on the heart and blood vessels
These include a reduced production of molecules that harm the arteries such as reactive oxygen species ROS and increasing the number of stem cells that help repair vessels called endothelial progenitor cells EPCs
Recent studies have shown that different statins might have different effects on protecting people from developing heart disease These differences may be due to differences in these non-cholesterol lowering processes and are the subject of this study
Standard of Care
The two statins that will be used in this study pravastatin Pravachol and atorvastatin Lipitor are approved for use in people with a high cholesterol level or heart disease These medications are generally very well tolerated with minimal side effects They are not approved for use in patients to increase the level of EPCs or to reduce the production of ROS and therefore are considered experimental for this indication Currently there are no drugs that are specifically approved for these indications
How the Problem Will be Studied
These statins will be given to patients who have high cholesterol and either diabetes or the metabolic syndrome once a day for 12 weeks We the investigators at Emory will measure the level of EPCs and ROS before and during the administration of the statin We will also investigate how well the blood vessels dilate in response to these medications by performing an imaging study of the forearm artery using ultrasound
The study is blinded and there is an equal chance of receiving either atorvastatin 10mg or pravastatin 80mg which are likely to lower cholesterol level by a similar amount
How Research Will Advance Scientific Knowledge
The goal of this study is to determine if atorvastatin will increase the number of circulating EPCs and reduce the production of ROS more than pravastatin This may help explain the differences between these drugs that have been observed in some recently published trials
A group of medications called statins commonly used worldwide to lower cholesterol levels are known to reduce the risk of heart disease through their effects on reducing cholesterol levels These medications also have effects beyond the lowering of cholesterol that may help mediate their beneficial effects on the heart and blood vessels
These include a reduced production of molecules that harm the arteries such as reactive oxygen species ROS and increasing the number of stem cells that help repair vessels called endothelial progenitor cells EPCs
Recent studies have shown that different statins might have different effects on protecting people from developing heart disease These differences may be due to differences in these non-cholesterol lowering processes and are the subject of this study
Standard of Care
The two statins that will be used in this study pravastatin Pravachol and atorvastatin Lipitor are approved for use in people with a high cholesterol level or heart disease These medications are generally very well tolerated with minimal side effects They are not approved for use in patients to increase the level of EPCs or to reduce the production of ROS and therefore are considered experimental for this indication Currently there are no drugs that are specifically approved for these indications
How the Problem Will be Studied
These statins will be given to patients who have high cholesterol and either diabetes or the metabolic syndrome once a day for 12 weeks We the investigators at Emory will measure the level of EPCs and ROS before and during the administration of the statin We will also investigate how well the blood vessels dilate in response to these medications by performing an imaging study of the forearm artery using ultrasound
The study is blinded and there is an equal chance of receiving either atorvastatin 10mg or pravastatin 80mg which are likely to lower cholesterol level by a similar amount
How Research Will Advance Scientific Knowledge
The goal of this study is to determine if atorvastatin will increase the number of circulating EPCs and reduce the production of ROS more than pravastatin This may help explain the differences between these drugs that have been observed in some recently published trials
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None