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Prevention of Atherosclerosis and Heart Disease in Patients With Systemic Lupus Erythematosis (SLE)
This study has been completed.
First Received: February 13, 2003   Last Updated: November 5, 2008   History of Changes
Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00054938
  Purpose

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.


Condition Intervention Phase
Systemic Lupus Erythematosus
Lupus
Drug: pravastatin
Drug: aspirin
Drug: ramipril
Drug: Vitamins: B6, B12, and folate
Behavioral: heart health educational program
Phase II

MedlinePlus related topics: Heart Diseases Lupus
Drug Information available for: Pravastatin Pravastatin sodium Ramipril
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title: A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 150
Study Start Date: March 2003
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00054938

Locations
United States, Massachusetts
Brigham and Women's Hospital, RBB Brigham Arthritis Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Brigham and Women's Hospital ( Matthew H. Liang, MD, MPH )
Study ID Numbers: P60 AR47782 NIAMS-077
Study First Received: February 13, 2003
Last Updated: November 5, 2008
ClinicalTrials.gov Identifier: NCT00054938     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
SLE
Accelerated Atherosclerosis
Cholesterol

Study placed in the following topic categories:
Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Autoimmune Diseases
Antilipemic Agents
Lupus
Vascular Diseases
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Ramipril
Folic Acid
Pravastatin
Lupus Erythematosus, Systemic
Aspirin
Vitamins
Connective Tissue Diseases

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

ClinicalTrials.gov processed this record on May 07, 2009