Rho Kinase in Patients With Atherosclerosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00115830 |
Recruitment Status :
Completed
First Posted : June 27, 2005
Last Update Posted : April 24, 2007
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atherosclerosis | Drug: Atorvastatin Drug: Rosuvastatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Rho Kinase in Patients With Atherosclerosis: Effects of Statins - A Double Blind, Randomized Clinical Trial Comparing Rosuvastatin and Atorvastatin |
Study Start Date : | December 2004 |
Actual Study Completion Date : | February 2007 |


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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115830
United States, Massachusetts | |
Brigham and Womens Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Andrew Selwyn, MD | Brigham and Womens Hospital |
ClinicalTrials.gov Identifier: | NCT00115830 |
Other Study ID Numbers: |
2004P-002254 |
First Posted: | June 27, 2005 Key Record Dates |
Last Update Posted: | April 24, 2007 |
Last Verified: | April 2007 |
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Atorvastatin Rosuvastatin Calcium |
Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |