Lupus Atherosclerosis Prevention Study

Systemic Lupus Erythematosus Clinical Trial

Official title: Lupus Atherosclerosis Prevention Study

Status Completed

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).

Clinical Trial Description

n/a

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

• NCT number: NCT00120887
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Completed
• Phase: Phase 4
• Start date: April 2002
• Completion date: December 2005