Help guide our efforts to modernize
Send us your comments by March 14, 2020. Menu

Lupus Atherosclerosis Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120887
Recruitment Status : Completed
First Posted : July 19, 2005
Last Update Posted : April 5, 2007
Lupus Research Alliance
Information provided by:
Johns Hopkins University

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).

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Atorvastatin Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Lupus Atherosclerosis Prevention Study
Study Start Date : April 2002
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Primary Outcome Measures :
  1. This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.
  2. Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.
  3. 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.
  4. Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.

Secondary Outcome Measures :
  1. Determine whether a statin has an immunomodulatory benefit on SLE disease activity.
  2. 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.
  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
  • Patients must be 18 years of age or older
  • Give informed consent.

Exclusion Criteria:

  • SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
  • Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
  • Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient’s racial group, are excluded.
  • Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00120887

Layout table for location information
United States, Maryland
Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Lupus Research Alliance
Layout table for investigator information
Principal Investigator: Michelle A Petri, M.D.,MPH Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00120887    
Other Study ID Numbers: LAPS
First Posted: July 19, 2005    Key Record Dates
Last Update Posted: April 5, 2007
Last Verified: September 2006
Keywords provided by Johns Hopkins University:
Atherosclerosis, SLE, statins
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors