A 12-week, randomised, double-blind study evaluating the effects of low-dose (10 mg) and high-dose (80 mg) atorvastatin on macrophage activity and carotid plaque inflammation as determined by ultra small super-paramagnetic iron oxide (USPIO) enhanced carotid magnetic resonance imaging (MRI)

GlaxoSmithKline (UK)0 sites40 target enrollmentMarch 29, 2006

Overview

Registry

who.int

Start Date

March 29, 2006

End Date

April 1, 2009

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline (UK)

•A subject will be eligible for inclusion in this study only if all of the following criteria are met:
•1\. Signed written informed consent prior to beginning study\-related procedures (subject must understand the aims, investigational procedures and possible consequences of the study)
•2\. Male or female aged 18 to 80 years of age at screening. Female subjects must be of non\-childbearing potential (post\-menopausal females who have been amenorrheic \>1 year, or pre\-menopausal females with a documented hysterectomy or bilateral oophorectomy).
•3\. Positive USPIO\-enhanced MRI of carotid plaque confirmed by a consultant neuroradiologist. This will be pre\-defined.
•4\. Must either be statin naive or have been on a stable dose of a statin for \=4 weeks prior to screening, with no evidence of statin intolerability

•A subject will not be eligible for inclusion in this study if any of the following criteria apply:
•1\. Required continued use of non\-statin lipid modifying therapies
•2\. History of statin intolerance
•3\. History of chronic viral hepatitis or other chronic hepatic disorders
•4\. Renal impairment
•5\. History of myopathy or inflammatory muscle disease
•6\. Doppler assessment of less than 40% stenosis during screening assessment
•7\. Contraindication to MRI scanning
•8\. Planned carotid surgery or endovascular intervention earlier than 10 weeks within the study period
•9\. Serum triglycerides \>400 mg/dl (4\.52 mmol/l) at screening