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

NCT00293748 | Completed

• 2 other identifiers: 06009706-N-0097
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Vascular Disease; Vascular Disease Risk

Keywords

Genomics; Statins; Coronary Heart Disease; Stroke; Inflammation; Gene Expression; Vascular Risk; Peripheral Blood Mononuclear Cells; Atorvastatin; Vascular Disease; Vascular Disease Risk

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). JAMA. 2001 May 16;285(19):2486-97. doi: 10.1001/jama.285.19.2486. No abstract available.

  PMID: 11368702 BACKGROUND

• Altman DG, Bland JM. How to randomise. BMJ. 1999 Sep 11;319(7211):703-4. doi: 10.1136/bmj.319.7211.703. No abstract available.

  PMID: 10480833 BACKGROUND

• Anderson KM, Odell PM, Wilson PW, Kannel WB. Cardiovascular disease risk profiles. Am Heart J. 1991 Jan;121(1 Pt 2):293-8. doi: 10.1016/0002-8703(91)90861-b.

  PMID: 1985385 BACKGROUND

MeSH Terms

Conditions

Vascular Diseases; Coronary Disease; Stroke; Inflammation

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: February 17, 2006
• First Posted: February 17, 2006
• Study Start: February 13, 2006
• Study Completion: December 15, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-12-15

Locations

US (1)