Fenofibrate in the Management of Abdominal Aortic Aneurysms 2

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001039774

Acronym

FAME2

Enrollment

140

Registered

2013-09-18

Start date

2013-11-01

Completion date

2015-09-11

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

Daily oral administration of 145mg of fenofibrate for 24 weeks. Drug tablet return will monitor adherence.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

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 criteria

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 150 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

Outcome results