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Tracking Information | |||||
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First Received Date † | July 12, 2005 | ||||
Last Updated Date | April 4, 2007 | ||||
Start Date † | April 2002 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
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Change History | Complete list of historical versions of study NCT00120887 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Lupus Atherosclerosis Prevention Study | ||||
Official Title † | Lupus Atherosclerosis Prevention Study | ||||
Brief Summary | Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement). |
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Detailed Description | |||||
Study Phase | Phase IV | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Systemic Lupus Erythematosus | ||||
Intervention † | Drug: Atorvastatin | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 200 | ||||
Completion Date | December 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00120887 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Johns Hopkins University | ||||
Collaborators †† | Alliance for Lupus Research | ||||
Investigators † |
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Information Provided By | Johns Hopkins University | ||||
Verification Date | September 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |