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Completed

NCT Number: NCT00120887

Lupus Atherosclerosis Prevention Study

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).

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Key information

Conditions

Systemic Lupus Erythematosus Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Lupus Center 1830 E Monument Street, Ste 7500

Baltimore, Maryland, 21205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

atorvastatin

Drug

Primary outcomes

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

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

  3. 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.

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

Secondary outcomes

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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Lupus Research Alliance

Registry information

Important dates

Study start
2002
Study completion
2005
First posted
Jul 19, 2005
Registry last updated
Apr 5, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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