Rowbotham Sophie E, Cavaye Doug, Jaeggi Rene, Jenkins Jason S, Moran Corey S, Moxon Joseph V, Pinchbeck Jenna L, Quigley Frank, Reid Christopher M, Golledge Jonathan
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.
Trials. 2017 Jan 4;18(1):1. doi: 10.1186/s13063-016-1752-z.
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.
METHODS/DESIGN: 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.
腹主动脉瘤（AAA）是腹主动脉的一种缓慢进展的破坏性病变。实验研究表明，贝特类药物通过涉及血清脂质调节和腹主动脉瘤壁有利变化的机制对腹主动脉瘤发挥有益作用。
方法/设计：非诺贝特治疗腹主动脉瘤（FAME）是一项多中心、随机、双盲、安慰剂对照的临床试验，旨在评估口服非诺贝特治疗对接受开放性腹主动脉瘤修复术患者腹主动脉瘤关键病理标志物的影响。共有42名计划接受择期开放性腹主动脉瘤修复术的参与者将被随机分配，在手术前至少2周每天服用145毫克非诺贝特或相同的安慰剂。主要结局指标将是腹主动脉瘤壁内的巨噬细胞数量和骨桥蛋白（OPN）浓度以及血清OPN浓度。次要结局指标将包括腹主动脉瘤壁、主动脉周围脂肪和壁内血栓内的基质金属蛋白酶和促炎细胞因子水平以及腹主动脉瘤生物标志物的循环浓度。
目前，尚无公认的药物疗法可限制腹主动脉瘤的进展。FAME试验旨在评估非诺贝特改变腹主动脉瘤病理组织标志物的能力。
澳大利亚新西兰临床试验注册中心，ACTRN12612001226897。于2012年11月20日注册。
