Rho Kinase in Patients With Atherosclerosis

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Brigham and Womens Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Rosuvastatin

Drug

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Rho Kinase in Patients With Atherosclerosis: Effects of Statins - A Double Blind, Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin

Important dates

Study start: 2004
Study completion: 2007
First posted: Jun 27, 2005
Registry last updated: Apr 24, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed