Fenofibrate in the Management of Abdominal Aortic Aneurysms 2
James Cook University
140 participants
Nov 1, 2013
Interventional
Conditions
Summary
FAME2 is a multi-centre, randomised, double-blind, placebo-controlled clinical trial. Participants will be randomised to receive fenofibrate (145mg daily for 24 weeks) or placebo (145mg daily for 24 weeks) in a parallel group, double blind design. Randomisation lists will be generated by a statistician and provided to the study centres ensuring both investigators and participants are blinded to drug assignment. Screening and randomization will occur at Visit 1 and 2. Participants will receive a phone call at three weeks in addition with a blood test, drug safety check and recording of any adverse events. Another phone call will occur at three months. Here again participants drug safety and compliance will be checked along with any adverse events. The final visit will occur at the end of six months.
Eligibility
Inclusion Criteria3
- Ability to provide written informed consent.
- Diagnosis of an asymptomatic abdominal aortic aneurysm which is infrarenal in location and 35-49mm in size.
- High likelihood of medication compliance.
Exclusion Criteria6
- Current use of any fenofibrate or related fibrates contra-indication to fenofibrate including; liver impairment demonstrated by abnormal liver function tests (greater than or equal to 1.5 times normal upper limit); renal impairment (serum creatinine greater than or equal to
- micromole); symptomatic gallbladder disease; previous reaction to any lipid modifying medication.
- Previous aortic surgery
- A Mycotic, symptomatic, ruptured or infected abdominal aortic aneurysm
- A requirement for emergency or urgent open abdominal aortic aneurysm repair
- Current enrolment in any other drug trial
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Interventions
Daily oral administration of 145mg of fenofibrate for 24 weeks. Drug tablet return will monitor adherence.
Locations(4)
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ACTRN12613001039774