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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Fenofibrate in the Management of Abdominal Aortic Aneurysms 2
Scientific title
Fenofibrate in the Management of Abdominal Aortic Aneurysms 2
Secondary ID [1] 283216 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abdominal Aortic Aneurysm
290081 0
Condition category
Condition code
Cardiovascular 290461 290461 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Daily oral administration of 145mg of fenofibrate for 24 weeks. Drug tablet return will monitor adherence.
Intervention code [1] 287943 0
Treatment: Drugs
Comparator / control treatment
Placebo. The placebo will be indentical in taste and appearance to fenofibrate but without the active ingredient. The frequency and duration of use will also be indentical to the active drug.
Control group

Primary outcome [1] 290489 0
Serum OPN concentration. This will be assessed on stored serum using the Quantikine R&D Systems ELISA according to manufactuer's instructions.
Timepoint [1] 290489 0
24 weeks post commencement of drug/placebo.
Primary outcome [2] 293435 0
Serum kallistatin concentration (ng/ml). This will be assessed on stored serum using the Quantikine R&D Systems ELISA according to the manufacturer's instructions.
Timepoint [2] 293435 0
24 weeks post commencement of drug/placebo
Secondary outcome [1] 304610 0
Serum resistin concentration. This will be measured using ELISA (R&D Systems) according to the manufacturer's instructions and expressed as nanogram per milliliter.
Timepoint [1] 304610 0
24 weeks post commencement of drug/placebo.
Secondary outcome [2] 304611 0
Serum lipids, including total cholesterol, triglycerides, LDL and HDL. These will be assessed on serum obtained from patients who have fasted overnight using automated assays.
Timepoint [2] 304611 0
24 weeks post commencement of drug/placebo.
Secondary outcome [3] 304612 0
Plasma MMP-9. The concentration of MMP-9 will be measured using an ELISA from R&D Systems.
Timepoint [3] 304612 0
24 weeks post commencement of drug/placebo.
Secondary outcome [4] 304613 0
Other markers of inflammation including full blood count, c-reactive protein, cell markers for T cells, B cells and neutrophils using automated assays and flow cytometry.
Timepoint [4] 304613 0
24 weeks post commencement of drug/placebo.
Secondary outcome [5] 304614 0
Abdominal aortic aneurysm diameter. This will be assessed by an ultrasound of the abdominal aorta.
Timepoint [5] 304614 0
24 weeks post commencement of drug/placebo.

Key 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.
Minimum age
No limit
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Trial participants who meet the inclusion/exclusion criteria and provide Informed Consent. FAME Randomisation was achieved through computer generated sequence allocation (NQuery Advisor Ver. 9). Central randomisation was carried out by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was blocked on a 1:1 ratio using mixed block sizes and stratified by recruitment site. All trial staff, investigators and participants are blinded to the randomisation schedule.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 1508 0
The Townsville Hospital - Douglas
Recruitment hospital [2] 1509 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 1511 0
Gosford Vascular Services
Recruitment hospital [4] 3785 0
Mackay Base Hospital - Mackay
Recruitment postcode(s) [1] 7348 0
4814 - Douglas
Recruitment postcode(s) [2] 7349 0
4006 - Herston
Recruitment postcode(s) [3] 7351 0
2250 - Gosford
Recruitment postcode(s) [4] 9666 0
4740 - Mackay

Funding & Sponsors
Funding source category [1] 287963 0
Government body
Name [1] 287963 0
National Health Medical Research Council (NHMRC)
Address [1] 287963 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 287963 0
Primary sponsor type
James Cook University
1 James Cook Drive
QLD 4811

Secondary sponsor category [1] 286682 0
Name [1] 286682 0
Address [1] 286682 0
Country [1] 286682 0

Ethics approval
Ethics application status
Ethics committee name [1] 289887 0
Metro North Hospital and Health Service
Ethics committee address [1] 289887 0
The Prince Charles Hospital
Administration Builing, Lower Ground, Rode Road, Chermside QLD 4032
Ethics committee country [1] 289887 0
Date submitted for ethics approval [1] 289887 0
Approval date [1] 289887 0
Ethics approval number [1] 289887 0

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 42478 0
Prof Jonathan Golledge
Address 42478 0
School of Medicine, James Cook University, 1 James Cook Drive, Douglas, Queensland 4811
Country 42478 0
Phone 42478 0
+61 7 4433 1417
Fax 42478 0
+61 7 4433 1401
Email 42478 0
Contact person for public queries
Name 42479 0
Dr Rene Jaeggi
Address 42479 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 42479 0
Phone 42479 0
+61 7 4781 3116
Fax 42479 0
+61 7 4781 3179
Email 42479 0
Contact person for scientific queries
Name 42480 0
Dr Rene Jaeggi
Address 42480 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 42480 0
Phone 42480 0
+61 7 4781 3116
Fax 42480 0
+61 7 4781 3179
Email 42480 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary