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

Completed

Conditions studied: Vascular Disease, Vascular Disease Risk

In brief

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.

Key facts

Study ID

NCT00293748

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

200

Starts

2006-02-13

Expected to finish

2008-12-15

Last updated by the study team

2017-07-02

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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