The Effects of Atorvastatin in Patients With Atherosclerosis
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.
- Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in patients with atherosclerosis.
- Any decrease in Rho kinase activity with statin therapy will be accompanied by improvement in familiar markers of atherosclerosis.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis|
|Study Start Date:||June 2005|
|Study Completion Date:||March 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115817
|United States, Massachusetts|
|Brigham and Womens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Andrew Selwyn, MD||Brigham and Womens Hospital|