The Effects of Atorvastatin in Patients With Atherosclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115817
Recruitment Status : Completed
First Posted : June 27, 2005
Last Update Posted : April 24, 2007
Information provided by:
Brigham and Women's Hospital

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.


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

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Atorvastatin Phase 3

Detailed Description:
The total study period is approximately 14 + 28 days. There will be a total of 5 visits: a screening visit, followed by visits at 0, 7, 14 and 28 days. (These dates may vary by approximately 2 days in the event of a weekend or holiday). At the baseline visit (day 0), patients will be randomly assigned to atorvastatin 10 mg/day (given as 1 placebo pill + 1 10mg pill), 80 mg/day (given as 2 40mg pills) or placebo (given as 2 placebo pills). Subjects will be asked to take 2 pills every day at the same time between 7 p.m. and 8 p.m., and record in a calendar/diary any side effects, missed doses, change in concomitant medication, or any other pertinent information. At each visit, blood will be collected for the following tests: 1) Lipid profile, 2) C-Reactive protein, 3) Rho kinase expression and activity in leukocytes, 4) nitric oxide synthase (NOS) expression/activity in platelets, and 5) leukocyte/monocyte adhesion/migration assays. Blood for hepatic and muscle tests (ALT, GGT and CK) to monitor for side effects will be determined at baseline and at 28 days and as clinically indicated. At each visit, patients will be questioned about compliance with study medication and any side effects. All patients will be encouraged to adhere to the NCEP-ATPIII recommended therapeutic life style. Subjects will be asked to resume any statin medications they were taking prior to enrollment upon completion of the study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis
Study Start Date : June 2005
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00115817

United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Andrew Selwyn, MD Brigham and Womens Hospital Identifier: NCT00115817     History of Changes
Other Study ID Numbers: 2005P-000416
First Posted: June 27, 2005    Key Record Dates
Last Update Posted: April 24, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors