Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115817
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-06-26
Brief Title:
The Effects of Atorvastatin in Patients With Atherosclerosis
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
The Effects of Atorvastatin on the RhoRho Kinase Pathway in Patients With Atherosclerosis
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 mgday given as 1 placebo pill 1 10mg pill 80 mgday 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 pm and 8 pm and record in a calendardiary 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 expressionactivity in platelets and 5 leukocytemonocyte adhesionmigration 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None