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Lupus Atherosclerosis Prevention Study

This study has been completed.
Sponsor:
Collaborator:
Alliance for Lupus Research
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00120887
First received: July 12, 2005
Last updated: April 4, 2007
Last verified: September 2006
History of Changes
  Purpose

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
Systemic Lupus Erythematosus
 Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Lupus Atherosclerosis Prevention Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 200
Study Start Date: April 2002
Estimated Study Completion Date: December 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120887

Locations
United States, Maryland
Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Alliance for Lupus Research
Investigators
Principal Investigator: Michelle A Petri, M.D.,MPH Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00120887     History of Changes
Other Study ID Numbers: LAPS
Study First Received: July 12, 2005
Last Updated: April 4, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Atherosclerosis, SLE, statins

Additional relevant MeSH terms:
Atherosclerosis
Lupus Erythematosus, Systemic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013