Lupus Atherosclerosis Prevention Study
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|ClinicalTrials.gov Identifier: NCT00120887|
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : April 5, 2007
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Atorvastatin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Lupus Atherosclerosis Prevention Study|
|Study Start Date :||April 2002|
|Study Completion Date :||December 2005|
- This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.
- Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.
- Determine whether atorvastatin 40 mg is more effective than placebo in preventing new or preventing progression of old atherosclerotic plaque on carotid duplex over two years.
- Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.
- Determine whether a statin has an immunomodulatory benefit on SLE disease activity.
- Determine whether there is a difference between atorvastatin and placebo arms in bone mineral density at one year, due either to improvement in, or prevention of, osteoporosis in the atorvastatin arm, or to progression in the placebo arm.
- Determine predictors of atherosclerosis in SLE, including: a) cardiovascular risk factors; b) measures of SLE activity, damage and health status; c) antiphospholipid antibodies; d) renal function; e) treatment; and f) sociodemographic variables.
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): NCT00120887
|United States, Maryland|
|Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Michelle A Petri, M.D.,MPH||Johns Hopkins University|