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Sponsors and Collaborators: |
Johns Hopkins University Alliance for Lupus Research |
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Information provided by: | Johns Hopkins University |
ClinicalTrials.gov Identifier: | NCT00120887 |
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).
Condition | Intervention | Phase |
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Systemic Lupus Erythematosus |
Drug: Atorvastatin |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Lupus Atherosclerosis Prevention Study |
Estimated Enrollment: | 200 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | December 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | LAPS |
Study First Received: | July 12, 2005 |
Last Updated: | April 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00120887 |
Health Authority: | United States: Institutional Review Board |
Atherosclerosis, SLE, statins |
Arterial Occlusive Diseases Atherosclerosis Autoimmune Diseases Lupus Erythematosus, Systemic |
Connective Tissue Diseases Vascular Diseases Arteriosclerosis Atorvastatin |
Antimetabolites Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Cardiovascular Diseases Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |