Lupus Atherosclerosis Prevention Study

April 4, 2007 updated by: Johns Hopkins University
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Lupus Research Alliance

Investigators

  • Principal Investigator: Michelle A Petri, M.D.,MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

July 12, 2005

First Submitted That Met QC Criteria

July 18, 2005

First Posted (Estimate)

July 19, 2005

Study Record Updates

Last Update Posted (Estimate)

April 5, 2007

Last Update Submitted That Met QC Criteria

April 4, 2007

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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