Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease
Vascular Disease, Vascular Disease Risk
About this trial
This is an observational trial for Vascular Disease focused on measuring Genomics, Statins, Coronary Heart Disease, Stroke, Inflammation, Gene Expression, Vascular Risk, Peripheral Blood Mononuclear Cells, Atorvastatin, Vascular Disease, Vascular Disease Risk
Eligibility Criteria
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
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike