ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613001039774

Ethics application status

Approved

Date submitted

13/09/2013

Date registered

18/09/2013

Date last updated

2/11/2021

Date data sharing statement initially provided

2/11/2021

Date results provided

2/11/2021

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]

None

Universal Trial Number (UTN)

U1111-1156-5755

Trial acronym

FAME2

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Abdominal Aortic Aneurysm

Condition category

Condition code

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

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

Placebo

Outcomes

Primary outcome [1]

Serum OPN concentration. This will be assessed on stored serum using the Quantikine R&D Systems ELISA according to manufactuer's instructions.

Timepoint [1]

24 weeks post commencement of drug/placebo.

Primary outcome [2]

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]

24 weeks post commencement of drug/placebo

Secondary outcome [1]

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]

24 weeks post commencement of drug/placebo.

Secondary outcome [2]

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]

24 weeks post commencement of drug/placebo.

Secondary outcome [3]

Plasma MMP-9. The concentration of MMP-9 will be measured using an ELISA from R&D Systems.

Timepoint [3]

24 weeks post commencement of drug/placebo.

Secondary outcome [4]

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]

24 weeks post commencement of drug/placebo.

Secondary outcome [5]

Abdominal aortic aneurysm diameter. This will be assessed by an ultrasound of the abdominal aorta.

Timepoint [5]

24 weeks post commencement of drug/placebo.

Eligibility

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

Sex

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

Treatment

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

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/10/2013

Actual

1/11/2013

Date of last participant enrolment

Anticipated

Actual

11/09/2015

Date of last data collection

Anticipated

Actual

22/04/2016

Sample size

Target

140

Accrual to date

Final

140

Recruitment in Australia

Recruitment state(s)

NSW,QLD

Recruitment hospital [1]

The Townsville Hospital - Douglas

Recruitment hospital [2]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [3]

Gosford Vascular Services

Recruitment hospital [4]

Mackay Base Hospital - Mackay

Recruitment postcode(s) [1]

4814 - Douglas

Recruitment postcode(s) [2]

4006 - Herston

Recruitment postcode(s) [3]

2250 - Gosford

Recruitment postcode(s) [4]

4740 - Mackay

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health Medical Research Council (NHMRC)

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

James Cook University

Address

1 James Cook Drive
Townsville
QLD 4811

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Metro North Hospital and Health Service

Ethics committee address [1]

The Prince Charles Hospital
Administration Builing, Lower Ground, Rode Road, Chermside QLD 4032

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2013

Approval date [1]

04/03/2013

Ethics approval number [1]

HREC/13/QPCH/16

Summary

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

http://ncre-pad.registry.org.au/clinical-studies

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Jonathan Golledge

Address

School of Medicine, James Cook University, 1 James Cook Drive, Douglas, Queensland 4811

Country

Australia

Phone

+61 7 4433 1417

Fax

+61 7 4433 1401

jonathan.golledge@jcu.edu.au

Contact person for public queries

Name

Rene Jaeggi

Address

College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811

Country

Australia

Phone

+61 7 4781 3116

Fax

+61 7 4781 3179

rene.jaeggi@jcu.edu.au

Contact person for scientific queries

Name

Rene Jaeggi

Address

College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811

Country

Australia

Phone

+61 7 4781 3116

Fax

+61 7 4781 3179

rene.jaeggi@jcu.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data sharing was not included in the protocol or consent form, therefore this data will not be available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
13906	Study protocol				https://www.ncbi.nlm.nih.gov/pmc/articles/PMC52098... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Randomized placebo-controlled trial assessing the effect of 24-week fenofibrate therapy on circulating markers of abdominal aortic aneurysm: Outcomes from the FAME-2 trial.	2018	https://dx.doi.org/10.1161/JAHA.118.009866

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically