Status:
COMPLETED
Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Vascular Disease
Vascular Disease Risk
Eligibility:
All Genders
21+ years
Brief Summary
This study will determine if the drug Atorvastatin (Lipitor) changes the genetic material found in blood cells of people with vascular (blood vessel) disease. Vascular diseases affect the blood flow i...
Detailed Description
Background: Atherosclerosis and its consequences - coronary heart disease and stroke - are principal causes of mortality in developed countries. Being able to accurately predict an individual's risk o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Age 21 or older
- Not taking a statin or other lipid-lowering drug and no history of statin use
- Two or more risk factors as listed below:
- Age (men greater than or equal to 45 years, women greater than or equal to 55 years)
- Hypertension (BP greater than or equal to 140/90 or on antihypertensive medication)
- Cigarette smoking
- Coronary heart disease equivalents (includes diabetes mellitus, abdominal aortic aneurysm, peripheral vascular disease, carotid artery disease)
- Prior stroke or transient ischemic attack
- Family history of premature coronary heart disease (CHD): CHD in male first degree relative less than 55 years or CHD in female first degree relative less than 65 years
- Total cholesterol greater than or equal to 240mg/dL and/or LDL cholesterol greater than or equal to 160 mg/dL
- Low HDL cholesterol (less than 40 mg/dL)
- Note: A high HDL cholesterol (greater than 60 mg/dL) counts as a negative risk factor: its presence removes one risk factor from the total counts.
- EXCLUSION CRITERIA
- Current or past history of statin use
- Assessed need for immediate statin treatment by subject's primary care physician
- Current use of an investigational drug as part of another research protocol
- Chronic or active liver disease
- Chronic or active muscle disease
- Alcohol abuse
- Prior myocardial infarct
- Heart failure
- Uncontrolled arrhythmias
- Any clinically important hematological or biochemical abnormality on routine screening
- Recent history of cancer
- Pregnant women or breast-feeding women
- Concomitant use of the following medications, including drugs that strongly inhibit CYP3A54: nicotinic acid, gemfibrozil, clofibrate, fenofibrate, verapamil, mibefradil, cyclcosporin, nefazodone, fluoxetine, paroxetine, ketoconazole, itraconazole, cimetadine, clarithromycin, erythromycin, protease inhibitors, NSAIDs, celebrex
Exclusion
Key Trial Info
Start Date :
February 13 2006
Trial Type :
OBSERVATIONAL
End Date :
December 15 2008
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00293748
Start Date
February 13 2006
End Date
December 15 2008
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892