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

Abstract

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">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. </span></p><p class="abstract"><strong>Methods:</strong> <span lang="EN-IN">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.</span></p><p class="abstract"><strong>Conclusions:</strong> This study represents the next step in the assessment of a potential novel medical therapy for AAA.</p>