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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Matthew H. Liang, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00054938
First received: February 13, 2003
Last updated: December 23, 2013
Last verified: December 2013

February 13, 2003
December 23, 2013
March 2003
December 2005   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00054938 on ClinicalTrials.gov Archive Site
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Not Provided
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Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Systemic Lupus Erythematosus
  • Lupus
  • Drug: pravastatin
  • Drug: aspirin
  • Drug: ramipril
  • Drug: Vitamins: B6, B12, and folate
  • Behavioral: heart health educational program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00054938
P60 AR47782 NIAMS-077, P60AR047782
Not Provided
Matthew H. Liang, MD, Brigham and Women's Hospital
Brigham and Women's Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
Brigham and Women's Hospital
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP