Effect of infLuenza vaccInation after Myocardial INfArction on cardiac inflammaTory responsE - a randomized, double-blind, placebo-controlled, trial (ELIMINATE trial)

INTERVENTION: Product Name: VaxigripTetra, injektionsvätska, suspension i förfylld spruta Fyrvalent influensavaccin (spjälkat virus, inaktiverat),Product Code: PRD4523973,Pharmaceutical Form: SUSPENSION FOR INJECTION,Other descriptive name: ,Strength: Influenza Virus A/Darwin/9/2021 San‐010 (H3n2) 15µg HA / 0.5mL, Influenza Virus B/Michigan/01/2021 15µg HA / 0.5mL, B/Phuket/3073/2013‐Like Virus (B/Phuket/3073/2013, Wild Type) 15µg HA / 0.5mL, Influenza A/Victoria/4897/2022 Ivr‐238 (H1n1), Inactivated 15µg HA / 0.5mL,Product Name: Natriumklorid B. Braun 9 mg/ml infusionsvätska, lösning,Product Code: PRD563959,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Sodium Chloride 9g / 1000mL,Pharmaceutical form of the placebo: SOLUTION FOR INFUSION,Route of administration of the placebo: INTRAMUSCULAR CONDITION: Myocardial infarction Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective:The primary objective is to compare influenza vaccination and placebo in reducing post myocardial infarction coronary inflammation as measured by CCTA. Primary end point(s):Change from baseline in pericoronary adipose tissue (PCAT) density (right coronary artery), a marker of coronary artery inflammation measured by CCTA, at week 8. Secondary Objective:To compare the differences from baseline in the average perivascular adipose tissue (PCAT) density of the whole coronary tree (main epicardial arteries =2mm) and the ascending aorta.,To compare changes in cytokine and chemokine profiles, and other markers of systemic inflammation between baseline and 8 weeks follow up in the two study groups.,To monitor the cardiac biomarkers at 8 weeks follow up. SECONDARY OUTCOME: Secondary end point(s):Cardiac biomarkers (troponin‐I, N‐terminal pro‐B‐type natriuretic peptide) at 8 weeks follow up Secondary end point(s):Change from baseline in the average PCAT density of the whole coronary tree (main epicardial arteries =2mm) Secondary end point(s):Change from baseline in the perivascular adipose tissue density of the ascending aorta Secondary end point(s):Differences in cytokine and chemokine profiles (including IL‐1ß, TNF‐a, IL‐2r, IL‐6), and other markers of systemic inflammation, (ferritin and high sensitivity CRP) at baseline and 8 weeks follow up Secondary end point(s):Exploratory endpoints: Differences in myeloid, T‐ and B cell subpopulations, their activation status and their gene expression signatures, measured by mass cytometry and single‐cell RNA sequencing, and differences in blood proteome, from baseline to 8 weeks. INCLUSION CRITERIA: 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 scan can be scheduled within 7 days after PCI