Status:
COMPLETED
Lupus Atherosclerosis Prevention Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Lupus Research Alliance
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in systemic lupus erythematosus (SLE) in developed countries. Coronary artery disease and stroke contribute t...
Eligibility Criteria
Inclusion
- Patients with a clinical diagnosis of SLE, confirmed by a faculty rheumatologist at Johns Hopkins.
- Patients must be 18 years of age or older
- Give informed consent.
Exclusion
- SLE patients with a known atherosclerotic event, such as angina, myocardial infarction, or stroke, with an abnormal lipid profile for which a statin would be standard of care, are excluded.
- Pregnant patients (or patients planning to become pregnant in the next two years) are excluded.
- Patients who have known chronic liver disease, have unexplained elevation of their liver enzymes greater than 2 times the upper limit of normal , or an elevated CPK greater than 1.5 times the upper limit of the normal value for the patient's racial group, are excluded.
- Patients with triglycerides greater than 500 mg/dl or LDL greater than 190 in the absence of 2 risk factors (and who are unwilling to participate in a formal nutritional/lifestyle modification program that we recommend for them) are excluded.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00120887
Start Date
April 1 2002
End Date
December 1 2005
Last Update
April 5 2007
Active Locations (1)
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1
Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500
Baltimore, Maryland, United States, 21205