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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Treatments: Aspirin; Pravastatin; Ramipril

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