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Rho Kinase in Patients With Atherosclerosis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00115830

First Posted: June 27, 2005

Last Update Posted: April 24, 2007

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.

Information provided by:

Brigham and Women's Hospital

Purpose

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.

Condition	Intervention	Phase
Atherosclerosis	Drug: Atorvastatin Drug: Rosuvastatin	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
Official Title:	Rho Kinase in Patients With Atherosclerosis: Effects of Statins - A Double Blind, Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis

Drug Information available for: Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin Atorvastatin calcium trihydrate

U.S. FDA Resources

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


Estimated Enrollment:	40
Study Start Date:	December 2004
Study Completion Date:	February 2007

Detailed Description:

A double-blind controlled trial with two arms will be conducted at Brigham and Women’s 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 (n=20) or 10mg of rosuvastatin (n=20) 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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	40 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female subjects aged 40 to 80 years
Documented stable atherosclerosis by angiography or vascular ultrasound (more that 20% luminal narrowing), previous myocardial infarction, ischemic stroke, peripheral arterial disease or type 2 diabetes mellitus (coronary heart disease (CHD) risk equivalent - Adult Treatment Program (ATP)-III guidelines)
LDL-cholesterol >100mg/dL (indication to treat with statin)
Written informed consent
Primary care physician authorization letter to participate in the study.

Exclusion Criteria:

Inability to give consent
Pre-menopausal women
Current use of antibiotics, anti-inflammatory or immunosuppressant drugs
History of LFT >2 times the upper normal limit
History of myopathy/myositis or CPK > 10 times the upper normal limit
CPK above normal limits at study onset
Any evidence of inflammatory, infectious or neoplastic disease
History of CABG, PCI or acute ischemic syndrome in the preceding 3 months

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00115830

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


ClinicalTrials.gov Identifier:	NCT00115830 History of Changes
Other Study ID Numbers:	2004P-002254
First Submitted:	June 26, 2005
First Posted:	June 27, 2005
Last Update Posted:	April 24, 2007
Last Verified:	April 2007

Additional relevant MeSH terms:


Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Atorvastatin Calcium Rosuvastatin Calcium	Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors

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