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
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Strategies for the Prevention of Accelerated Atherosclerosis in Systemic Lupus Erythematosus - A Pilot Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Brigham and Women's Hospital
Investigators
Principal Investigator: Matthew H. Liang, MD, MPH Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Matthew H. Liang, MD, Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00054938     History of Changes
Other Study ID Numbers: P60 AR47782 NIAMS-077, P60AR047782
Study First Received: February 13, 2003
Last Updated: December 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Brigham and Women's Hospital:
SLE
Accelerated Atherosclerosis
Cholesterol

Additional relevant MeSH terms:
Atherosclerosis
Lupus Erythematosus, Systemic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Aspirin
Ramipril
Pravastatin
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on July 09, 2014