A Trial of Rosuvastatin in Systemic Lupus Erythematosus

NCT01170585 | Completed Phase 2 DMC

• 1 other identifier: 2006-006214-16
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

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.

Conditions

Atherosclerosis; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• Change from baseline in bilateral carotid artery wall volume and distensibility

  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.

  3 CMR of 24 months (baseline; 12 and 24 mnths)

Secondary Outcomes (2)

• Endothelial function assessed by brachial artery reactivity.

  3 CMR, baseline; 12 and 24 mnths.

• Correlation of vascular findings to ventricular volumes and function

  baseline; 12 and 24 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

randomised to placebo.

Drug: Placebo

Active

ACTIVE COMPARATOR

randomised to rosuvastatin.

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

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.

Also known as: Crestor

Active

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Imperial College NHS Trust

London, London, United Kingdom

Location

North West London Hospitals NHS Trust

London, London, United Kingdom

Location

MeSH Terms

Conditions

Atherosclerosis; Lupus Erythematosus, Systemic

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Dudley J Pennell, MD

  CMR Unit, Royal Brompton Hospital, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: July 1, 2010
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

GB (2)