Rho Kinase in Patients With Atherosclerosis
1 other identifier
interventional
40
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 26, 2005
CompletedFirst Posted
Study publicly available on registry
June 27, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedApril 24, 2007
April 1, 2007
June 26, 2005
April 23, 2007
Conditions
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Selwyn, MD
Brigham and Womens Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 26, 2005
First Posted
June 27, 2005
Study Start
December 1, 2004
Study Completion
February 1, 2007
Last Updated
April 24, 2007
Record last verified: 2007-04