Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)

December 23, 2013 updated by: Matthew H. Liang, MD, Brigham and Women's Hospital

A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study

The purpose of this study is to find the best way to prevent heart disease and stroke in people with lupus (systemic lupus erythematosis, or SLE). The study will evaluate the effectiveness of medication and a phone-based education program in controlling four risk factors for heart disease: smoking, obesity, high blood pressure, and inactivity. The study will also test the safety of commonly used heart medications in people with lupus.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

People with SLE are at much higher risk for mortality due to atherosclerotic vascular disease (ASVD). Available data suggest that the usual mechanics of and risk factors for atherosclerosis are enhanced by factors such as corticosteroid use and SLE itself. This study will evaluate a medication and education program designed to prevent ASVD complications (primary prevention) or their recurrence (secondary prevention). The study will also measure the compliance and retention rate for the prevention program over 4 years.

Participants in this study will be randomized to receive either preventive heart disease medications or placebo. Participants in the medication arm will receive pravastatin alone or in combination with the following: aspirin, ramipril, or a combination of vitamins B6, B12, and folate. All participants in this study will receive basic education on how to optimize their heart health. Educational material will be sent to the patients as well as to support persons whom they have named. One group will receive tailored education based on a particular risk factor. Participants will have three study visits and follow-up telephone visits four times a year. Study visits will include a medical history and basic laboratory blood tests. Participants with documented high blood pressure will receive a home monitoring unit and be asked to monitor their blood pressure. Participants will be followed for 2 to 4 years.

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital, RBB Brigham Arthritis Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • SLE as defined by the 1997 American College of Rheumatology criteria
  • Acceptable methods of contraception

Exclusion Criteria

  • Participation in another experimental protocol for ASVD prevention
  • Heavy alcohol consumption ( >= 3 drinks/day)
  • Aspirin intolerance
  • Certain medications, including coumadin, ACE inhibitors, potassium supplements, potassium sparing diuretics, cyclosporine, and lithium
  • Peptic ulcer disease within 6 months prior to study entry
  • History of an intracranial bleed or brain tumor
  • Bleeding diathesis
  • History of allergy or sensitivity to ACE inhibitors
  • Uncontrolled high blood pressure (180 mm Hg/110 mm Hg)
  • Creatinine > 2.0 mg/dl
  • Renal artery stenosis
  • Pregnant or breastfeeding
  • Abnormal liver function tests (ALT > 2 X upper limit of normal)
  • History of a muscle disease, or baseline CPK > 500U/L or 2 X upper limit of normal

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: DOUBLE

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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

March 1, 2003

Primary Completion (ACTUAL)

December 1, 2005

Study Completion (ACTUAL)

December 1, 2005

Study Registration Dates

First Submitted

February 13, 2003

First Submitted That Met QC Criteria

February 13, 2003

First Posted (ESTIMATE)

February 14, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2013

Last Update Submitted That Met QC Criteria

December 23, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P60 AR47782 NIAMS-077
  • P60AR047782 (U.S. NIH Grant/Contract)

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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