The Effects of Atorvastatin in Patients With Atherosclerosis

NCT00115817 | Completed Phase 3 DMC

• 1 other identifier: 2005P-000416
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effects of Atorvastatin. The investigators want to find out if atorvastatin has other helpful qualities. The investigators are interested in finding out if medicines like atorvastatin are useful even in people who do not have high levels of bad cholesterol and would like to understand other mechanisms by which this medicine helps prevent further blood vessel disease. Hypotheses:

1. 1.Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in patients with atherosclerosis.
2. 2.Any decrease in Rho kinase activity with statin therapy will be accompanied by improvement in familiar markers of atherosclerosis.

Conditions

Atherosclerosis

Interventions

Atorvastatin DRUG

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects aged 21 to 80 years
• Modified NCEP ATPIII guideline criteria should be met to initiate statin therapy
• Known stable atherosclerotic disease (diagnosed coronary, peripheral or carotid vascular disease) and/or diabetes mellitus (a coronary heart disease equivalent)
• Written informed consent with prior primary care physician approval

You may not qualify if:

• Inability to give consent
• Pregnancy
• Inability to withdraw statin therapy for a 6 week period
• Prior history of intolerance to statins
• Hepatic dysfunction (ALT or GGT \> 2 times the upper limit of normal
• Elevated muscle enzymes (CK \> 3 times the upper limit of normal)
• History of myopathy or myositis
• Evidence of active inflammatory, infectious or neoplastic disease
• Use of cyclosporine, fibric acid derivatives, nicotinic acid, erythromycin, azole antifungals, prednisone or any immunosuppressant
• Coronary artery bypass graft surgery or percutaneous coronary intervention within the preceding 3 months
• Acute coronary syndrome or myocardial infarction within the preceding 3 months
• History of life-threatening arrhythmias without an implantable cardioverter defibrillator
• Severe chronic congestive heart failure
• Severe anemia
• Serum creatinine \> 3 mg/dl

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Andrew Selwyn, MD

  Brigham and Womens Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 26, 2005
• First Posted: June 27, 2005
• Study Start: June 1, 2005
• Study Completion: March 1, 2007
• Last Updated: April 24, 2007

Record last verified: 2007-04

Locations

US (1)