Trial Review

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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 information initially 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] 283216 0
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
 290081 0
Condition category
Condition code
Cardiovascular 290461 290461 0 0
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] 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
Placebo

Outcomes
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.

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?
No
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] 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)
Country [1] 287963 0
Australia
Primary sponsor type
University
Name
James Cook University
Address
1 James Cook Drive
Townsville
QLD 4811
Country
Australia
Secondary sponsor category [1] 286682 0
None
Name [1] 286682 0
Address [1] 286682 0
Country [1] 286682 0

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 289887 0
25/01/2013
Approval date [1] 289887 0
04/03/2013
Ethics approval number [1] 289887 0
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 42478 0
Prof Jonathan Golledge
Address 42478 0
School of Medicine, James Cook University, 1 James Cook Drive, Douglas, Queensland 4811
Country 42478 0
Australia
Phone 42478 0
+61 7 4433 1417
Fax 42478 0
+61 7 4433 1401
Email 42478 0
[email protected]
Contact person for public queries
Name 42479 0
Rene Jaeggi
Address 42479 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 42479 0
Australia
Phone 42479 0
+61 7 4781 3116
Fax 42479 0
+61 7 4781 3179
Email 42479 0
[email protected]
Contact person for scientific queries
Name 42480 0
Rene Jaeggi
Address 42480 0
College of Medicine and Dentistry, James Cook University,
1 James Cook Drive, Douglas, Queensland 4811
Country 42480 0
Australia
Phone 42480 0
+61 7 4781 3116
Fax 42480 0
+61 7 4781 3179
Email 42480 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.TypeCitationLinkEmailOther DetailsAttachment
13906Study protocol    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC52098... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://www.ahajournals.org/doi/10.1161/JAHA.118.0... [More Details]
Other filesNo 3rd September 2018, Townsville Hospital & Health S... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRandomized placebo-controlled trial assessing the effect of 24-week fenofibrate therapy on circulating markers of abdominal aortic aneurysm: Outcomes from the FAME-2 trial.2018https://dx.doi.org/10.1161/JAHA.118.009866
N.B. These documents automatically identified may not have been verified by the study sponsor.