Status:
COMPLETED
Rho Kinase in Patients With Atherosclerosis
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Atherosclerosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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 doct...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00115830
Start Date
December 1 2004
End Date
February 1 2007
Last Update
April 24 2007
Active Locations (1)
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1
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115