Status:
COMPLETED
The Effects of Atorvastatin in Patients With Atherosclerosis
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Atherosclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The total study period is approximately 14 + 28 days. There will be a total of 5 visits: a screening visit, followed by visits at 0, 7, 14 and 28 days. (These dates may vary by approximately 2 days in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00115817
Start Date
June 1 2005
End Date
March 1 2007
Last Update
April 24 2007
Active Locations (1)
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1
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115