Effect of Atorvastatin (Lipitor) on Gene Expression in People With Vascular Disease

Study 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 in the body and can lead to a heart attack or stroke. Information gained from this study could be used to develop a more reliable blood test that predicts the risk of heart attack or stroke. People 21 and older who have two or more risk factors for developing vascular disease are eligible for this study. Candidates are screened with a medical history, physical examination, electrocardiogram, ultrasound of the carotid (neck) arteries, blood tests, and check of blood pressure and heart rate. Participants are randomly assigned to one of four treatment groups. Three groups receive Lipitor in a dose of either 10, 20 or 40 milligrams; the fourth group receives a placebo. All take the study drug for 3 months. In addition, they undergo the following tests and procedures: Study Phase I (Months 2-4) Participants in all groups are seen once a month at the NIH Clinical Center for blood tests and monitoring of drug side effects. Study Phase 2 (Months 5-10) * Placebo group: Participants are given 40 mg of Lipitor for 3 months (months 5-7) and seen by a physician once a month during that time. Blood is drawn at the 7-month visit and then participants are referred back to their physicians. During months 8, 9 and 10, participants are called once a month to check on their health. Participation ends after the tenth month. * Lipitor group: Participants are referred back to their physicians for months 5 and 6 and are called once a month. During month 7, they return to the clinic for a follow-up evaluation and blood test. Participation ends after the seventh month.