Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001296628
Ethics application status
Approved
Date submitted
16/11/2023
Date registered
13/12/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
13/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluate the effectiveness of Acute Flu Vaccination on Recurrent Cardiovascular Events (AFLUENT): A Pilot Randomised Clinical Trial
Scientific title
Evaluate the effectiveness of Acute Flu Vaccination on Recurrent Cardiovascular Events (AFLUENT): A Pilot Randomised Clinical Trial
Secondary ID [1] 310935 0
None
Universal Trial Number (UTN)
Trial acronym
AFLUENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute myocardial infarction (Type 1) 331996 0
Condition category
Condition code
Cardiovascular 328736 328736 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
AFLUENT is a pragmatic, investigator initiated, open label, randomised, pilot clinical trial that will be undertaken within the Cardiology department at Royal Perth Hospital.

This trial will compare an intervention of “early” routine influenza vaccination of patients diagnosed with acute myocardial infarction within one week of the event, to “standard care”, where patients will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their primary care physician.

If a patient is randomised to the intervention of the influenza vaccination, a delegated research nurse who has undertaken an accredited immunisation course will administer the intramuscular vaccination prescribed by the treating physician on the Cardiology wards at Royal Perth Hospital.
Intervention code [1] 327364 0
Prevention
Comparator / control treatment
Patients randomised to the control group will not receive the influenza vaccine. These patients will still receive routine standard care, of which they will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their primary care physician.
Control group
Active

Outcomes
Primary outcome [1] 336547 0
Composite primary outcome, including incidence of cardiovascular death, myocardial infarction and stroke.
Timepoint [1] 336547 0
12 months after randomisation.
Secondary outcome [1] 428761 0
Composite secondary outcome, including the primary outcome plus hospitalisation for unstable angina requiring unplanned revascularisation.
Timepoint [1] 428761 0
12 months after randomisation.
Secondary outcome [2] 428762 0
Quality of life
Timepoint [2] 428762 0
12 months after randomisation.
Secondary outcome [3] 429515 0
Incidence of cardiovascular death
Timepoint [3] 429515 0
12 months after randomisation
Secondary outcome [4] 429516 0
Myocardial infarction
Timepoint [4] 429516 0
12 months post randomisation
Secondary outcome [5] 429517 0
Stroke
Timepoint [5] 429517 0
12 months post randomisation
Secondary outcome [6] 429518 0
All cause death
Timepoint [6] 429518 0
12 months post randomisation
Secondary outcome [7] 429519 0
Days alive and out of hospital
Timepoint [7] 429519 0
12 months post randomisation

Eligibility
Key inclusion criteria
Acute type 1 myocardial infarction
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Influenza vaccination in the previous 3 months
b) Previous anaphylactic reaction to influenza vaccination
c) Previous anaphylactic reaction to any component of influenza vaccine (if no suitable alternate vaccine is available)
d) Intercurrent active infection or febrile illness
e) Prior history of Guillain-Barré Syndrome within 6 weeks of previous influenza vaccination
f) Other severe medical condition with life expectancy <1 year
g) Unable or unwilling to provide informed consent.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible patients that agree to participate in the trial will be randomised by the delegated research coordinator using the randomisation module in a computer generated randomisation schedule.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Primary Outcome (time to event) will be measured from randomisation until event or last known event-free observation during the follow-up period (12 months). Patients not experiencing the primary outcome event will have their time to event censored at last follow-up date. The primary outcome will be compared between each intervention group using restricted mean survival analyses, a point estimate, 95% confidence interval and 2-sided p-value. Statistical significance will occur if the p-value is <0.05. The primary analysis will follow the intention to treat principle. A secondary analysis will be performed based on whether patients did or did not receive any influenza vaccination during the trial period.

Secondary Outcome will be analysed using appropriate methodology: time to event using restricted mean survival analysis, binary outcomes using logistic regression, continuous outcomes using linear regression or where not normally distributed using appropriate non-parametric methods.

Exploratory analyses will compare the outcomes a) in patients randomised during ‘flu season’ with those randomised at other times and b) in patients who had received influenza vaccination in the year prior to randomisation with those who had not. We will also compare outcomes in important subgroups such as patients with diabetes, patients = or > 75 years, men and women etc.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25830 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 41657 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 315245 0
University
Name [1] 315245 0
Curtin University
Country [1] 315245 0
Australia
Primary sponsor type
Hospital
Name
Royal Perth Hospital
Address
197 Wellington St, Perth WA 6000
Country
Australia
Secondary sponsor category [1] 317275 0
None
Name [1] 317275 0
Address [1] 317275 0
Country [1] 317275 0
Other collaborator category [1] 282875 0
University
Name [1] 282875 0
The University of Western Australia
Address [1] 282875 0
35 Stirling Hwy, Crawley WA 6009
Country [1] 282875 0
Australia
Other collaborator category [2] 282876 0
University
Name [2] 282876 0
Curtin University
Address [2] 282876 0
Kent St, Bentley WA 6102
Country [2] 282876 0
Australia
Other collaborator category [3] 282877 0
Hospital
Name [3] 282877 0
Royal Perth Hospital
Address [3] 282877 0
197 Wellington Street, Perth WA 6000
Country [3] 282877 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314123 0
Royal Perth Hospital Human Research Ethics Committee
Ethics committee address [1] 314123 0
Level 2, Kirkman House, 198 Wellington Street, Perth, Western Australia 6000
Ethics committee country [1] 314123 0
Australia
Date submitted for ethics approval [1] 314123 0
15/11/2023
Approval date [1] 314123 0
07/02/2024
Ethics approval number [1] 314123 0
RGS0000006476

Summary
Brief summary
AFLUENT is a pragmatic, investigator initiated, open label, randomised, pilot clinical trial that will be undertaken within the Cardiology department at Royal Perth Hospital.

This trial will compare an intervention of “early” routine influenza vaccination of patients diagnosed with acute myocardial infarction within one week of the event, to “standard care”, where patients will be advised to seek their influenza vaccination in the community at their own discretion with guidance from their primary care physician.

As per guideline recommendations, it is specifically recommended that “high risk” cardiac patients such as those within this study population receive their influenza vaccination in the community prior to the onset of “flu season”. However, enrolment of trial patients into AFLUENT will occur all year round, regardless of whether it is “flu season” or not. It is anticipated that patients within the “standard care” group may delay their vaccination or not receive it at all. Thus, the trial is testing a strategy of routine early administration to all patients in the intervention group, with currently recommended strategy whereby patients are encouraged to access vaccination in the community but often do not. The likely failure of many control patients to seek vaccination plus the inevitable delay in doing so are fundamental to the design of this trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130490 0
Prof Graham Hillis
Address 130490 0
Department of Cardiology, Level 4, South Block, Royal Perth Hospital, Victoria Square, Perth, WA, 6000
Country 130490 0
Australia
Phone 130490 0
+61 8 9224 3180
Fax 130490 0
Email 130490 0
Graham.Hillis@health.wa.gov.au
Contact person for public queries
Name 130491 0
Ms Justine Chan
Address 130491 0
Department of Cardiology, Level 4, South Block, Royal Perth Hospital, Victoria Square, Perth, WA, 6000
Country 130491 0
Australia
Phone 130491 0
+61 8 9224 3281
Fax 130491 0
Email 130491 0
Justine.Chan@health.wa.gov.au
Contact person for scientific queries
Name 130492 0
Prof Graham Hillis
Address 130492 0
Department of Cardiology, Level 4, South Block, Royal Perth Hospital, Victoria Square, Perth, WA, 6000
Country 130492 0
Australia
Phone 130492 0
+61 8 9224 3180
Fax 130492 0
Email 130492 0
Graham.Hillis@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.