NCT00054938

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2003

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2003

Completed
15 days until next milestone

Study Start

First participant enrolled

March 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

December 24, 2013

Status Verified

December 1, 2013

Enrollment Period

2.8 years

First QC Date

February 13, 2003

Last Update Submit

December 23, 2013

Conditions

Systemic Lupus ErythematosusLupus

Keywords

SLEAccelerated AtherosclerosisCholesterol

Interventions

pravastatinDRUG
aspirinDRUG
ramiprilDRUG
Vitamins: B6, B12, and folateDRUG
heart health educational programBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital, RBB Brigham Arthritis Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

  • Liang MH, Mandl LA, Costenbader K, Fox E, Karlson E. Atherosclerotic vascular disease in systemic lupus erythematosus. J Natl Med Assoc. 2002 Sep;94(9):813-9.

    PMID: 12392045BACKGROUND

  • Costenbader KH, Liang MH. SLE - Practical and theoretical barriers to the prevention of accelerated atherosclerosis in systemic lupus erythematosus. Arthritis Res Ther. 2003;5(4):178-9. doi: 10.1186/ar773. Epub 2003 May 23.

    PMID: 12823848BACKGROUND

  • Costenbader KH, Karlson EW, Gall V, de Pablo P, Finckh A, Lynch M, Bermas B, Schur PH, Liang MH. Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus. Arthritis Rheum. 2005 Oct 15;53(5):718-23. doi: 10.1002/art.21441.

    PMID: 16208639RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

PravastatinAspirinRamiprilVitamin B 12Folic Acid

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds, 4 or More RingsMacrocyclic CompoundsPterinsPteridines

Study Officials

  • Matthew H. Liang, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 13, 2003

First Posted

February 14, 2003

Study Start

March 1, 2003

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

December 24, 2013

Record last verified: 2013-12

Locations

US(1)