Status:
COMPLETED
A Trial of Rosuvastatin in Systemic Lupus Erythematosus
Lead Sponsor:
Imperial College London
Conditions:
Atherosclerosis
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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...
Detailed Description
Systemic lupus erythematosus (SLE) is an auto-immune condition, multisystem, connective tissue disorder with a wide spectrum of disease (D'Cruz et al 2007), which includes cardiovascular manifestation...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01170585
Start Date
July 1 2010
End Date
June 1 2014
Last Update
June 23 2015
Active Locations (2)
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1
Imperial College NHS Trust
London, London, United Kingdom
2
North West London Hospitals NHS Trust
London, London, United Kingdom