The Effects of Atorvastatin in Patients With Atherosclerosis

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00115817
First received: June 26, 2005
Last updated: April 23, 2007
Last verified: April 2007
  Purpose

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. 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 Intervention Phase
Atherosclerosis
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 36
Study Start Date: June 2005
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115817

Locations
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Andrew Selwyn, MD Brigham and Womens Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00115817     History of Changes
Other Study ID Numbers: 2005P-000416
Study First Received: June 26, 2005
Last Updated: April 23, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014