Lupus Atherosclerosis Prevention Study

Systemic Lupus Erythematosus Clinical Trial

Official title:

Lupus Atherosclerosis Prevention Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120887
• Other study ID #: LAPS
• Status: Completed
• Phase: Phase 4
• First received: July 12, 2005
• Last updated: April 4, 2007
• Start date: April 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2006
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 to long-term morbidity in surviving patients. Atherosclerosis in SLE is multifactorial, with immune/inflammatory endothelial damage, traditional cardiovascular risk factors, and prothrombotic factors all playing important roles. Multiple groups have shown that hyperlipidemia is predictive of later atherosclerosis in SLE. In the general population, statins have become the drug of choice in preventing atherosclerotic events, through two mechanisms: lipid lowering that helps to prevent progression, and stabilization of plaques to prevent rupture. In the Lupus Atherosclerosis Prevention Trial we will determine if atorvastatin reduces the progression of atherosclerosis on helical computed tomography (CT) and carotid duplex. Recent work has confirmed that statins have an immunomodulatory role. This study will also determine whether statins improve clinical lupus activity or lupus serologies (anti-dsDNA and complement).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• Atorvastatin

Locations

Country	Name	City	State
United States	Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Alliance for Lupus Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This clinical trial of atorvastatin 40 mg vs. placebo will determine if atorvastatin will:. Reduce progression of atherosclerosis on helical CT or carotid duplex.
Primary	Determine whether atorvastatin 40 mg is more effective than placebo in retarding coronary calcification on multislice helical CT over two years.
Primary	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.
Primary	Determine whether atorvastatin 40 mg is more effective than placebo in preventing carotid intimal medial thickness on carotid duplex over two years.
Secondary	Determine whether a statin has an immunomodulatory benefit on SLE disease activity.
Secondary	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.
Secondary	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.