Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115830
Status:
COMPLETED
Last Update Posted:
2007-04-24
First Post:
2005-06-26
Brief Title:
Rho Kinase in Patients With Atherosclerosis
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Rho Kinase in Patients With Atherosclerosis Effects of Statins - A Double Blind Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin
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 investigate the effects of atorvastatin Lipitor and rosuvastatin Crestor United States Food and Drug Administration FDA approved drugs commonly prescribed by doctors to lower cholesterol on certain functions of platelets cells that cause blood clots white blood cells cells that are responsible for inflammation and blood flow regulation by arteries This is important because we are looking at ways to more effectively prevent atherosclerosis plaque buildup in blood vessels and heart disease Many studies have demonstrated that these drugs are effective at reducing inflammation and stabilizing plaques We are interested in better understanding the effects of these medicines on inflammation pain and swelling and the mechanism by which they act
Hypothesis Atorvastatin 40mg will reduce inflammatory markers and activity more than Rosuvastatin 10mg in spite of equal LDL-C reduction
Hypothesis Atorvastatin 40mg will reduce inflammatory markers and activity more than Rosuvastatin 10mg in spite of equal LDL-C reduction
Detailed Description:
A double-blind controlled trial with two arms will be conducted at Brigham and Womens Hospital BWH We will screen subjects with stable atherosclerosis to complete enrollment of 40 subjects in the study see inclusion and exclusion criteria section below A central pharmacist at BWH will randomize the patients to 40mg of atorvastatin n20 or 10mg of rosuvastatin n20 for 28 days If the patient is already on a statin a two-week washout period will be required prior to trial initiation Our subjects clinicians data collectors outcomes assessors and statisticians will be blind with regards to the patient allocation There are a total of 3 visits for each patient a short screening visit an initial visit for baseline data 90 min and a final visit after 28 days Our participants will be asked to take the medication every day at the same time between 9pm and 10pm Each visit will take place between 7am and 9am Patients will be instructed to fast overnight for a minimum of 8hrs They will also be advised not to make any other changes to their current medications and lifestyle for 28 days while in the study and to record in a diary any side effects missed doses or changes in concomitant medication
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