MedDataX Logo

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

NCT ID: NCT00054938

Last Updated: 2013-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2005-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus Lupus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

SLE Accelerated Atherosclerosis Cholesterol

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pravastatin

Intervention Type DRUG

aspirin

Intervention Type DRUG

ramipril

Intervention Type DRUG

Vitamins: B6, B12, and folate

Intervention Type DRUG

heart health educational program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matthew H. Liang, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matthew H. Liang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital, RBB Brigham Arthritis Center

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12392045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12823848 (View on PubMed)

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.

Reference Type RESULT
PMID: 16208639 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P60AR047782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P60 AR47782 NIAMS-077

Identifier Type: -

Identifier Source: org_study_id