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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02831608




Registration number
NCT02831608
Ethics application status
Date submitted
7/07/2016
Date registered
13/07/2016

Titles & IDs
Public title
Study on the Effect of Influenza Vaccination After Heart Attack on Future Cardiovascular Prognosis
Scientific title
Influenza Vaccination After Myocardial Infarction (IAMI Trial): A Multicenter, Prospective, Randomized Controlled Clinical Trial Based on National Angiography and Angioplasty Registries
Secondary ID [1] 0 0
IAMI Trial
Secondary ID [2] 0 0
IAMI-2014
Universal Trial Number (UTN)
Trial acronym
IAMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial Infarction 0 0
Influenza, Human 0 0
Influenza Vaccines 0 0
Heart Failure 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Drug: influenza vaccine - Standard influenza vaccine administered as a deep subcutaneous injection at one occasion per subject.

Placebo comparator: Drug: placebo - Saline administered as a deep subcutaneous injection at one occasion per subject.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of participants with death, a new myocardial infarction or stent thrombosis (first occurring) according to ICD-10 codes.
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
The number of participants with stroke/transient ischemic attack according to ICD-10 codes.
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
The number of participants with hospitalization for heart failure according to ICD-10 codes.
Timepoint [2] 0 0
1 year
Secondary outcome [3] 0 0
Length of hospital stay per participant.
Timepoint [3] 0 0
Pertains only to hospital stay at baseline. Realistic time frame: till 2 weeks
Secondary outcome [4] 0 0
The number of participants with: cardiovascular death, a new myocardial infarction or stent thrombosis assessed separately for each diagnosis according ICD-10 codes.
Timepoint [4] 0 0
1 year
Secondary outcome [5] 0 0
The number of participants with: cardiovascular death according to ICD-10 codes.
Timepoint [5] 0 0
1 year
Secondary outcome [6] 0 0
The number of participants with a new revascularization
Timepoint [6] 0 0
1 year
Secondary outcome [7] 0 0
The number of participants with: death according to ICD-10 codes.
Timepoint [7] 0 0
1 year
Secondary outcome [8] 0 0
The number of participants with: a new myocardial infarction according to ICD-10 codes.
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
The number of participants with: stent thrombosis.
Timepoint [9] 0 0
1 year
Secondary outcome [10] 0 0
The number of participants with: arrhythmia according to ICD-10 codes.
Timepoint [10] 0 0
1 year

Eligibility
Key inclusion criteria
* Patients with a diagnosis of ST-elevation myocardial infarction (STEMI) or
* Patients with a diagnosis of non-STEMI or
* Patients with stable coronary artery disease =75 years of age undergoing angiography/PCI AND with at least one additional risk criterion

and

* A finalized coronary angiography/PCI (optional for sites in Bangladesh).
* Male or female subjects =18 years.
* Written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Influenza vaccination during the current influenza season or anticipating to be vaccinated during the current influenza season.
* Indication for influenza vaccination for some indication other than myocardial infarction.
* Severe allergy to eggs or previous allergic reaction to influence vaccine.
* Suspicion of febrile illness or acute, ongoing infection.
* Hypersensitivity to the active substances or ingredients of Vaxigrip or against any residues, such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde and octoxinol.
* Subjects with endogenic or iatrogenic immunosuppression that may result in reduced immunization response.
* Inability to provide informed consent.
* Age below 18 years.
* Previous randomization in the IAMI 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2021
Sample size
Target
Accrual to date
Final
2571
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Bangladesh
State/province [1] 0 0
Dhaka
Country [2] 0 0
Czechia
State/province [2] 0 0
Brno
Country [3] 0 0
Czechia
State/province [3] 0 0
Praha
Country [4] 0 0
Denmark
State/province [4] 0 0
Aalborg
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
Denmark
State/province [7] 0 0
Odense
Country [8] 0 0
Latvia
State/province [8] 0 0
Riga
Country [9] 0 0
Norway
State/province [9] 0 0
Oslo
Country [10] 0 0
Sweden
State/province [10] 0 0
Göteborg
Country [11] 0 0
Sweden
State/province [11] 0 0
Jönköping
Country [12] 0 0
Sweden
State/province [12] 0 0
Karlstad
Country [13] 0 0
Sweden
State/province [13] 0 0
Linköping
Country [14] 0 0
Sweden
State/province [14] 0 0
Lund
Country [15] 0 0
Sweden
State/province [15] 0 0
Stockholm
Country [16] 0 0
Sweden
State/province [16] 0 0
Umea
Country [17] 0 0
Sweden
State/province [17] 0 0
Uppsala
Country [18] 0 0
Sweden
State/province [18] 0 0
Västerås
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Fife
Country [20] 0 0
United Kingdom
State/province [20] 0 0
Aberdeen
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Dundee
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Edinburgh
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Glasgow

Funding & Sponsors
Primary sponsor type
Other
Name
Ole Frobert, MD, PhD
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Swedish Heart Lung Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Sanofi Pasteur, a Sanofi Company
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Uppsala University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Lytics
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

TypeCitations or Other Details
Journal Frobert O, Gotberg M, Erlinge D, Akhtar Z, Christi... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02831608