Rho Kinase in Patients With Atherosclerosis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Atorvastatin; Atorvastatin Calcium; Rosuvastatin Calcium

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