- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115817
The Effects of Atorvastatin in Patients With Atherosclerosis
The Effects of Atorvastatin on the Rho/Rho Kinase Pathway in Patients With Atherosclerosis
The purpose of the study is to evaluate the effects of Atorvastatin.
The investigators want to find out if atorvastatin has other helpful qualities. The investigators are interested in finding out if medicines like atorvastatin are useful even in people who do not have high levels of bad cholesterol and would like to understand other mechanisms by which this medicine helps prevent further blood vessel disease.
Hypotheses:
- Atorvastatin reduces Rho kinase activity (in leukocytes) rapidly, within days, in patients with atherosclerosis.
- Any decrease in Rho kinase activity with statin therapy will be accompanied by improvement in familiar markers of atherosclerosis.
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham and Womens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female subjects aged 21 to 80 years
- Modified NCEP ATPIII guideline criteria should be met to initiate statin therapy
- Known stable atherosclerotic disease (diagnosed coronary, peripheral or carotid vascular disease) and/or diabetes mellitus (a coronary heart disease equivalent)
- Written informed consent with prior primary care physician approval
Exclusion Criteria:
- Inability to give consent
- Pregnancy
- Inability to withdraw statin therapy for a 6 week period
- Prior history of intolerance to statins
- Hepatic dysfunction (ALT or GGT > 2 times the upper limit of normal
- Elevated muscle enzymes (CK > 3 times the upper limit of normal)
- History of myopathy or myositis
- Evidence of active inflammatory, infectious or neoplastic disease
- Use of cyclosporine, fibric acid derivatives, nicotinic acid, erythromycin, azole antifungals, prednisone or any immunosuppressant
- Coronary artery bypass graft surgery or percutaneous coronary intervention within the preceding 3 months
- Acute coronary syndrome or myocardial infarction within the preceding 3 months
- History of life-threatening arrhythmias without an implantable cardioverter defibrillator
- Severe chronic congestive heart failure
- Severe anemia
- Serum creatinine > 3 mg/dl
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Andrew Selwyn, MD, Brigham and Womens Hospital
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- 2005P-000416
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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