Rho Kinase in Patients With Atherosclerosis

Completed · Phase 3

Conditions studied: Atherosclerosis

In brief

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.

Key facts

Study ID

NCT00115830

Run by

Brigham and Women's Hospital

People needed

40

Starts

2004-12-01

Expected to finish

2007-02-01

Last updated by the study team

2007-04-24

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Brigham and Womens Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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