Lupus Atherosclerosis Prevention Study

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00120887
• Date of registration: 12/07/2005
• Prospective Registration: No
• Primary sponsor: Johns Hopkins University
• Public title: Lupus Atherosclerosis Prevention Study
• Scientific title: Lupus Atherosclerosis Prevention Study
• Date of first enrolment: April 2002
• Target sample size: 200
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00120887
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Michelle A Petri, M.D.,MPH
• Affiliation: Johns Hopkins University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: Atorvastatin

Primary Outcome(s)

Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.

This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.

Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.

Determine whether atorvastatin 40 mg is more effective than placebo in preventing new or preventing progression of old atherosclerotic plaque on carotid duplex over two years.

Secondary Outcome(s)

Determine predictors of atherosclerosis in SLE, including: a) cardiovascular risk factors; b) measures of SLE activity, damage and health status; c) antiphospholipid antibodies; d) renal function; e) treatment; and f) sociodemographic variables.

Determine whether there is a difference between atorvastatin and placebo arms in bone mineral density at one year, due either to improvement in, or prevention of, osteoporosis in the atorvastatin arm, or to progression in the placebo arm.

Determine whether a statin has an immunomodulatory benefit on SLE disease activity.

Secondary ID(s)

LAPS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alliance for Lupus Research