Abstract
BackgroundAbdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. Experimental studies indicate that fibrates exert beneficial effects on AAAs by mechanisms involving both serum lipid modification and favourable changes to the AAA wall.Methods/designFenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a multicentre, randomised, double-blind, placebo-controlled clinical trial to assess the effect of orally administered therapy with fenofibrate on key pathological markers of AAA in patients undergoing open AAA repair. A total of 42 participants scheduled for an elective open AAA repair will be randomly assigned to either 145 mg of fenofibrate per day or identical placebo for a minimum period of 2 weeks prior to surgery. Primary outcome measures will be macrophage number and osteopontin (OPN) concentration within the AAA wall as well as serum concentrations of OPN. Secondary outcome measures will include levels of matrix metalloproteinases and proinflammatory cytokines within the AAA wall, periaortic fat and intramural thrombus and circulating concentrations of AAA biomarkers.DiscussionAt present, there is no recognised medical therapy to limit AAA progression. The FAME trial aims to assess the ability of fenofibrate to alter tissue markers of AAA pathology.Trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12612001226897. Registered on 20 November 2012.
Highlights
Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery
The FAME trial aims to assess the ability of fenofibrate to alter tissue markers of AAA pathology
Study design and participants Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME) is a multicentre, randomised, doubleblind, placebo-controlled clinical trial to assess the effect of orally administered therapy with fenofibrate on key pathological markers of AAA in patients undergoing open AAA repair
Summary
Abdominal aortic aneurysm (AAA) is a slowly progressive destructive process of the main abdominal artery. An abdominal aortic aneurysm (AAA) is defined as a progressive dilation of the infrarenal aorta, and is associated with a risk of fatal rupture which increases at larger AAA diameters [1, 2]. The incidence of AAA increases with advancing age, with approximately 5% of men and approximately 1% of women aged over 65 years having an AAA [3,4,5,6,7]. Small AAAs (30–54 mm in diameter) are typically asymptomatic and may be detected as an Identification of an effective drug therapy to limit AAA progression would represent a significant advancement in clinical management.
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