Acute Myocardial InfarctionPhase 4ELIMINATENCT06336317
Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE
A Phase 4 study testing Influenza vaccine in people with Acute Myocardial Infarction and Cardiovascular Diseases, run by Region Örebro County at 3 sites in 3 countries.
Trial summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Cardiovascular Diseases, Inflammatory Response
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 24 Apr 2024to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of non-ST-segment elevation myocardial infarction
- A finalized coronary PCI
- Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
- Written informed consent
- A CCTA can be scheduled within 7 days after PCI
Who cannot join
- Has received influenza vaccination within 6 months
- Other vaccination planned within 8 weeks (including covid-19 booster doses)
- Severe allergy to eggs or previous allergic reaction to influenza vaccine
- Cardiac surgery or staged PCI planned within 8 weeks
- Coronary stent involving the proximal RCA
- Suspicion of febrile illness or acute, ongoing infection
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- 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
- Previous randomization in the ELIMINATE trial
- Any non-cardiovascular condition, e.g. malignancy, with a life expectancy of less than 1 year based on the investigator´s clinical judgement.
- Contraindication to coronary CT angiography (e.g., inability to lie flat, contraindication to glyceryl trinitrate, previous contrast allergy or contrast-induced nephropathy, severe renal impairment [eGFR <30 mL/min/1.73 m2])
- Atrial fibrillation
- Uncontrolled chronic inflammatory disease
- Unable to comply with protocol requirements
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital, Department of Cardiology
Aarhus, DK-8200
Bjarne Linde Nørgaard, MD, PhD, +45 78 45 00 00, bnorgaard@dadlnet.dk
Sweden1 site, 1 recruiting
- Recruiting
Örebro University Hospital
Örebro, 70185
Sara Cajander, +46702261026, sara.cajander@oru.se
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Joseph Cheriyan, Dr, 01223 336517, jc403@cam.ac.uk
About this study
Official title: Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:
Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.
Read the detailed description
Following informed consent patients are randomized in a 1:1 fashion to influenza vaccination or placebo up to 7 days following PCI. Blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion. Patients will undergo CTCA at baseline (≤ 7 days of an AMI) and 8 weeks after PCI.
- Being tested
- Influenza vaccine, Placebo
- Keywords
- Coronary computed tomography angiography, Percutaneous coronary intervention, Influenza vaccine, Non ST-segment elevation myocardial infarction
- Medical subject headings
- Cardiovascular Diseases, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02
PlaceboBiological
Sodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01
| Study group | Role | What they receive |
|---|---|---|
| Vaccination arm | Active comparator | Influenza vaccine (Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02) Receives: Biological: Influenza vaccine |
| Placebo arm | Placebo comparator | Sodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The right coronary artery
Primary endpoint definition is a difference in pericoronary adipose tissue density (perivascular fat attenuation index) around the right coronary artery (RCA) measured by repeated CCTA imaging
Measured: Between baseline and 8 weeks follow up.
Secondary outcomes (9)
The whole coronary tree
Change from baseline in the average pericoronary adipose tissue density of the whole coronary tree (main epicardial arteries ≥2mm).
Measured: Between baseline and 8 weeks follow up.
Ascending aorta
Change from baseline in the perivascular adipose tissue density of the ascending aorta
Measured: Between baseline and 8 weeks follow up.
Interleukin 1 beta (IL-1β)
Difference in peripheral blood IL-1β concentrations
Measured: Between baseline and 8 weeks follow up.
Tumor necrosis factor alpha (TNF-α)
Difference in peripheral blood TNF-α concentrations
Measured: Between baseline and 8 weeks follow up.
Interleukin-2 receptor (IL-2r)
Difference in peripheral blood IL-2r concentrations
Measured: Between baseline and 8 weeks follow up.
Interleukin Interleukin-6 (IL-6 )
Difference in peripheral blood IL-6 concentrations
Measured: Between baseline and 8 weeks follow up.
Ferritin
Difference in peripheral blood ferritin concentrations
Measured: Between baseline and 8 weeks follow up.
Troponin-I
Differences in peripheral blood troponin-I concentrations between study groups
Measured: At 8 weeks follow up.
N-terminal pro-B-type natriuretic peptide
Differences in peripheral blood N-terminal pro-B-type natriuretic peptide concentrations between study groups
Measured: At 8 weeks follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start24 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Heart and Lung Association, Örebro University, Sweden, University of Cambridge, Aarhus University Hospital, Cambridge University Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Sara Cajander, MD, Principal investigator, Region Örebro länOle Frøbert, professor, Study chair, Region Örebro län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06336317
- Sponsor's protocol ID
- ELIMINATE-2024
- Acronym
- ELIMINATE
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE - a Randomized, Double-blind, Placebo-controlled, Trial (ELIMINATE Trial)
- ClinicalTrials.gov ID
- NCT06336317
- Acronym / sponsor ID
- ELIMINATE / ELIMINATE-2024
- Keywords
- Coronary computed tomography angiography, Percutaneous coronary intervention, Influenza vaccine, Non ST-segment elevation myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- The Swedish Heart and Lung Association, Örebro University, Sweden, University of Cambridge, Aarhus University Hospital, Cambridge University Hospitals NHS Foundation Trust
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized, double-blind, placebo-controlled clinical trial is to investigate the immunological effects of influenza vaccination outside of the influenza season on arterial inflammation in patients with a recent acute myocardial infarction (AMI). The primary objective is to compare the effects of influenza vaccination to those of a placebo in reducing post-myocardial infarction coronary inflammation as measured by coronary computed tomography angiography (CCTA). The main questions it aims to answer are:
Does influenza vaccination reduce arterial inflammation as measured by CCTA at week 8 after percutaneous coronary intervention (PCI) in comparison to baseline? Does influenza vaccination modulate systemic inflammation as measured by blood biomarkers and in-vitro challenge tests at week 8 after PCI in comparison to baseline? Researchers will compare the effects of influenza vaccination with those of a placebo.
Detailed description
Following informed consent patients are randomized in a 1:1 fashion to influenza vaccination or placebo up to 7 days following PCI. Blood tests for immune cell phenotyping and transcriptomic and proteomic analyses will be collected at baseline and 8 weeks after study inclusion. Patients will undergo CTCA at baseline (≤ 7 days of an AMI) and 8 weeks after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccination arm | Active comparator | Biological: Influenza vaccineInfluenza vaccine (Inactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02) |
| Placebo arm | Placebo comparator | Biological: PlaceboSodium Chloride (Placebo) Solution for infusion, 9mg/ml ATC code: B05BB01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of non-ST-segment elevation myocardial infarction
- A finalized coronary PCI
- Male or non-fertile female subjects ≥18 years. (Females without childbearing potential, postmenopausal women and women with a history of hysterectomy or other medical conditions that preclude pregnancy)
- Written informed consent
- A CCTA can be scheduled within 7 days after PCI
Key exclusion criteria (15 listed)
- Has received influenza vaccination within 6 months
- Other vaccination planned within 8 weeks (including covid-19 booster doses)
- Severe allergy to eggs or previous allergic reaction to influenza vaccine
- Cardiac surgery or staged PCI planned within 8 weeks
- Coronary stent involving the proximal RCA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccineInactivated, split virus or surface antigen Suspension for injection, prefilled syringe ATC code: J07BB02 | Biological | Vaccination arm |
| PlaceboSodium Chloride Solution for infusion, 9mg/ml ATC code: B05BB01 | Biological | Placebo arm |
Primary outcome
The right coronary artery
Time frame: Between baseline and 8 weeks follow up.
Primary endpoint definition is a difference in pericoronary adipose tissue density (perivascular fat attenuation index) around the right coronary artery (RCA) measured by repeated CCTA imaging
9 secondary outcomes
The whole coronary tree
Time frame: Between baseline and 8 weeks follow up.
Ascending aorta
Time frame: Between baseline and 8 weeks follow up.
Interleukin 1 beta (IL-1β)
Time frame: Between baseline and 8 weeks follow up.
Tumor necrosis factor alpha (TNF-α)
Time frame: Between baseline and 8 weeks follow up.
Interleukin-2 receptor (IL-2r)
Time frame: Between baseline and 8 weeks follow up.
Interleukin Interleukin-6 (IL-6 )
Time frame: Between baseline and 8 weeks follow up.
Ferritin
Time frame: Between baseline and 8 weeks follow up.
Troponin-I
Time frame: At 8 weeks follow up.
N-terminal pro-B-type natriuretic peptide
Time frame: At 8 weeks follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Cajander, MD principal investigator
Region Örebro län
Ole Frøbert, professor study chair
Region Örebro län
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza vaccine in people with Acute Myocardial Infarction and Cardiovascular Diseases, run by Region Örebro County at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Cajander, MD (+46196021042 ext. +46196021000, sara.cajander@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The right coronary artery (time frame: Between baseline and 8 weeks follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.