Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2: the study protocol for a multi-centre, randomised, placebo-controlled trial


  • Sophie E. Rowbotham Queensland Research Centre for Peripheral Vascular Disease; College of Medicine and Dentistry, James Cook University, Townsville QLD 4811, Australia
  • Bernie Bourke Gosford Vascular Services, Gosford NSW 2250, Australia
  • Michael Bourke Queensland Research Centre for Peripheral Vascular Disease; College of Medicine and Dentistry, James Cook University, Townsville QLD 4811, Australia; Gosford Vascular Services, Gosford NSW 2250, Australia
  • Rene Jaeggi Queensland Research Centre for Peripheral Vascular Disease; College of Medicine and Dentistry, James Cook University, Townsville QLD 4811, Australia
  • Jason S. Jenkins Department of Vascular Surgery, The Royal Brisbane and Women’s Hospital, Herston QLD 4029, Australia
  • Joseph V. Moxon Queensland Research Centre for Peripheral Vascular Disease; College of Medicine and Dentistry, James Cook University, Townsville QLD 4811, Australia
  • Jenna L. Pinchbeck Queensland Research Centre for Peripheral Vascular Disease; College of Medicine and Dentistry, James Cook University, Townsville QLD 4811, Australia
  • Christopher M. Reid School of Public Health, Curtin University, Perth, WA 6000, Australia; School of Public Health and Preventive Medicine, Monash University, Melbourne VIC 3004, Australia
  • Ramesh Velu Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville QLD 4814, Australia
  • Jonathan Golledge Department of Vascular and Endovascular Surgery, The Townsville Hospital, Townsville QLD 4814, Australia




Abdominal aortic aneurysm, Fenofibrate, Clinical trial, Osteopontin, Kallistatin


Background: Abdominal aortic aneurysms (AAAs) are a leading cause of mortality worldwide but have no recognised medical therapy. Pre-clinical studies indicate that osteopontin plays an important role in the pathogenesis of AAA via a number of mechanisms. This trial aims to assess the potential of fenofibrate to favourably alter biomarkers associated with AAA pathology.

Methods: Fenofibrate in the management of AbdoMinal aortic anEurysm (FAME)-2 is a multi-centre, prospective, randomised, double-blind, placebo-controlled clinical trial to assess the effect of 24 weeks of oral therapy with 145 mg of fenofibrate on key pathological markers of AAA. A total of 140 participants with an AAA measuring between 35-49 mm will be randomly assigned to either 145 mg of fenofibrate once per day or identical placebo for a period of 24 weeks. Primary outcome measures will be serum concentrations of osteopontin and kallistatin. Secondary outcome measures will include serum levels of resistin, lipids, matrix metalloproteinases and pro-inflammatory cytokines, circulating concentrations of AAA biomarkers, and AAA diameter as assessed by ultrasound.

Conclusions: This study represents the next step in the assessment of a potential novel medical therapy for AAA.


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