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A Trial of Rosuvastatin in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01170585
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : June 23, 2015
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

Systemic Lupus Erythematosus (SLE) is a condition that affects the whole body. It can cause inflammation of the blood vessels resulting in an earlier thickening and hardening of the arteries resulting in strokes. It has been reported that SLE can worsen the function resulting in heart failure.

The aim of the study is to examine what effects Rosuvastatin, a cholesterol lowering drug, given to patients has on the degree of thickening of the arteries over the course of two years. We also want to see how it affects the function of the blood vessels and also of the heart.

Individuals who agree to participate will be randomly assigned into two groups. One group will be given the active drug whereas the other will have a placebo. Subjects in the study will all have a cardiac magnetic resonance (CMR) scan before treatment, at 1 year and then 2 years at the end of the treatment. Each scan will involve imaging the carotid arteries in the neck, the arteries in the arm and also the heart. Individuals will continue to have regular out-patient reviews by their own team of doctors, regular blood tests will be taken to monitor the disease and also to ensure the safety and well being of the individual.

At the end of the 2 year study we hope that we will be able to slow down the rate of arterial thickening and retard any plaque build up in the arteries. We also want to see what effect rosuvastatin has on heart function. Ultimately, we hope to prove that people with SLE should be treated with a cholesterol lowering drug as part of their routine treatment.

Condition or disease Intervention/treatment Phase
Atherosclerosis Systemic Lupus Erythematosus Drug: Rosuvastatin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Trial of Rosuvastatin in Systemic Lupus Erythematosus
Study Start Date : July 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Placebo Comparator: Placebo
randomised to placebo.
Drug: Placebo

Active Comparator: Active
randomised to rosuvastatin.
Drug: Rosuvastatin
All patients will be uptitrated from an initial start dose of 5mg to 20mg rosuvastatin. This will be given once a day for 2 years.
Other Name: Crestor

Primary Outcome Measures :
  1. Change from baseline in bilateral carotid artery wall volume and distensibility [ Time Frame: 3 CMR of 24 months (baseline; 12 and 24 mnths) ]

    A series of 20 contiguous 2 dimensional images, centred about the carotid bifurcation will be obtained. These images are then used to calculate the vessel area, but because they are contiguous a three dimensional structure can be formed and the vessel volume can be calculated. These values can be plotted against age and sex-matched graphs of normal ranges.

    The carotid artery distensibility will be calculated by obtaining a short cine film of the carotid artery as it pulsates. This can be contoured in the diastolic and systolic phases of the cardiac cycle.

Secondary Outcome Measures :
  1. Endothelial function assessed by brachial artery reactivity. [ Time Frame: 3 CMR, baseline; 12 and 24 mnths. ]
    Endothelial function is assessed by imaging the area of the brachial artery at baseline & post intervention.Endothelial dependent function will be assessed by inflating a blood pressure cuff around the forearm for 5 minutes to occlude arterial blood flow and create hyperaemia on release which induces brachial artery dilation by shear effects on endothelium.Glyceryl trinitrate spray will be given to the patient, and further images will be obtained.Both sets of images will be compared to the baseline and the percentage change in vessel size calculated providing a measure of endothelial function.

  2. Correlation of vascular findings to ventricular volumes and function [ Time Frame: baseline; 12 and 24 months ]
    The correlation of ventricular indices in SLE patients is determined through assessment of cardiac function. Patients will have left and right ventricular volumes measured, allowing calculation of the ejection fraction. These will be compared with age and sex matched normal subjects

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with SLE-as diagnosed by ACR criteria
  • Male or females who are 18-80years of age, inclusive at screening
  • Female subjects who are post menopausal (i.e >6mnths without menstrual period), surgically sterile, or using effective contraceptive measures at visit 0 and the same contraception throughout the study and for 30days after discontinuing treatment
  • No current or previous statin therapy
  • No current indication for statin therapy (Coronary artery disease; hypercholesterolemia, renal dysfunction)
  • Subjects who have given their signed consent to participate in the study

Exclusion Criteria:

  • Patient < 18 or > 80 years
  • Contraindications for MRI - patients with pacemakers' defibrillators or pacing wires in the heart, or other metal implants such as metal in the eye, brain or spine. Other metallic devices or implants will have to be declared by the participant and assessed to be safe prior to having an MRI current or previous statin
  • Known atherosclerotic valvular disease
  • Renal dysfunction
  • Hyperlipidemia
  • Active myositis
  • All forms of liver disease
  • Pregnancy
  • Breastfeeding
  • Patients being treated with Cyclosporin A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01170585

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United Kingdom
Imperial College NHS Trust
London, United Kingdom
North West London Hospitals NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
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Principal Investigator: Dudley J Pennell, MD CMR Unit, Royal Brompton Hospital, London

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Responsible Party: Imperial College London Identifier: NCT01170585    
Other Study ID Numbers: 2006-006214-16
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: June 23, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors