Myocardial infarction MedDRA version: 20.0 Level: PT Classification code 10028596 Term: Myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: VaxigripTetra
Pharmaceutical Form: Solution for injection in pre-filled syringe
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutane
Sponsors
Örebro University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of =0.2 mV in leads V2-V3 and/or =0.1 mV in other leads or a probable new-onset left bundle branch block Or: - Patients with a diagnosis of NSTEMI defined by a combination of: onset of symptoms such as central chest pain or an aggravated angina pectoris, with or without an ECG change with ST-segment lowering or an inverted T-wave, and at least two values with levels of troponin-T or troponin-I above the established margin of an AMI. Or: - Patients with a diagnosis of stable coronary artery disease =75 years of age undergoing angiography/PCI AND with at least one additional risk criterion - previous myocardial infarction, previous PCI, previous CABG, diabetes mellitus, current smoking or an estimated glomerular filtration rate (eGFR) =65 years) yes F.1.3.1 Number of subjects for this age range 2200
Exclusion criteria
Exclusion criteria: - Influenza vaccination during the current influenza season or the subject 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 immunisation response. - Inability to provide informed consent. - Age below 18 years. - Previous randomization in the IAMI trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In a multicenter, prospective, randomized registry-based controlled clinical trial based on the SCAAR and SWEDEHEART platforms and other national registries in the participating countries to compare influenza vaccination and placebo in reducing future major adverse cardiac and cerebrovascular events in patients with myocardial infarction or stable coronary artery disease and an increased risk of future cardiovascular events.;Secondary Objective: Separate evaluation of each of the endpoints in the composite primary endpoint and time to revascularization, stroke, rehospitalization for heart failure and length of hospital stay.;Primary end point(s): The primary endpoint is time to all-cause death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year. These data will be obtained from national health registries. All primary endpoints up to 350 days will be adjudicated by a central adjudication committee.;Timepoint(s) of evaluation of this end point: One year after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time to all-cause death till 1 year. - Time to cardiovascular death till 1 year. - Time to stent thrombosis till 1 year. - Time to revascularization till 1 year. - Time to myocardial infarction till 1 year. - Time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) till 1 year. - Time to stroke including transient ischemic attack (TIA) till 1 year. - Time to hospitalization for heart failure. - Length of hospital stay (if information is available). ;Timepoint(s) of evaluation of this end point: - Time to all-cause death after 1 year. - Time to cardiovascular death after 1 year. - Time to stent thrombosis after 1 year. - Time to revascularization after 1 year. - Time to myocardial infarction after 1 year. - Time to cardiovascular death, a new myocardial infarction or stent thrombosis (first occurring) after 1 year. - Time to stroke including transient ischemic attack (TIA) after 1 year. - Time to hospitalization for heart failure after 1 year. - Length of hospital stay (if information is available). | — |
Countries
Czech Republic, Denmark, Latvia, Norway, Sweden, United Kingdom
Contacts
Public ContactDepartment of Cardiology
Örebro University hospital
Outcome results
None listed