title: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME): study protocol for a randomised controlled trial.
abstract: Abdominal 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.
  
  
  
  Fenofibrate 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.
  
  
  
  At 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.
  
  
  
  Australian New Zealand Clinical Trials Registry, ACTRN12612001226897 . Registered on 20 November 2012.
authors.affiliation: The University of Queensland, School of Medicine, Herston, QLD, 4006, Australia.|Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, QLD, 4029, Australia.
authors.forename: Sophie E
authors.initials: SE
authors.lastname: Rowbotham
authors.affiliation: Department of Vascular Surgery. Holy Spirit Northside Private Hospital, Chermside, QLD, 4032, Australia.
authors.forename: Doug
authors.initials: D
authors.lastname: Cavaye
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, James Cook University, Townsville, QLD, 4811, Australia.|College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.
authors.forename: Rene
authors.initials: R
authors.lastname: Jaeggi
authors.affiliation: Department of Vascular Surgery, The Royal Brisbane and Women's Hospital, Herston, QLD, 4029, Australia.
authors.forename: Jason S
authors.initials: JS
authors.lastname: Jenkins
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, James Cook University, Townsville, QLD, 4811, Australia.|College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.
authors.forename: Corey S
authors.initials: CS
authors.lastname: Moran
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, James Cook University, Townsville, QLD, 4811, Australia.|College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.
authors.forename: Joseph V
authors.initials: JV
authors.lastname: Moxon
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, James Cook University, Townsville, QLD, 4811, Australia.|College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia.
authors.forename: Jenna L
authors.initials: JL
authors.lastname: Pinchbeck
authors.affiliation: Mater Medical Centre, Pimlico, QLD, 4812, Australia.
authors.forename: Frank
authors.initials: F
authors.lastname: Quigley
authors.affiliation: School of Public Health, Curtin University, Perth, WA, 6000, Australia.|School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, 3004, Australia.
authors.forename: Christopher M
authors.initials: CM
authors.lastname: Reid
authors.affiliation: Queensland Research Centre for Peripheral Vascular Disease, James Cook University, Townsville, QLD, 4811, Australia. jonathan.golledge@jcu.edu.au.|College of Medicine and Dentistry, James Cook University, Townsville, QLD, 4811, Australia. jonathan.golledge@jcu.edu.au.|Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville, QLD, 4811, Australia. jonathan.golledge@jcu.edu.au.
authors.forename: Jonathan
authors.identifier: 0000-0002-5779-8848
authors.initials: J
authors.lastname: Golledge
mesh_terms: D000284:Administration, Oral; D017544:Aortic Aneurysm, Abdominal / Q000097:blood / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D015415:Biomarkers / Q000097:blood; D002985:Clinical Protocols; D016207:Cytokines / Q000378:metabolism; D004311:Double-Blind Method; D011345:Fenofibrate / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008264:Macrophages / Q000187:drug effects / Q000378:metabolism; D020782:Matrix Metalloproteinases / Q000378:metabolism; D053495:Osteopontin / Q000097:blood; D011793:Queensland; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D016207:Cytokines; D000960:Hypolipidemic Agents; C506895:SPP1 protein, human; D053495:Osteopontin; D020782:Matrix Metalloproteinases; D011345:Fenofibrate
keywords: Abdominal aortic aneurysm; Clinical trial; Fenofibrate; Macrophage; Osteopontin