E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028596 |
E.1.2 | Term | Myocardial infarction |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Sub study 1.
"IAMI response. The immune response to influenza vaccine in a subpopulation of IAMI." date; 2018-08-24, version 2.0.
The first aim is to determine the response to influenza vaccine in ACS patients by using HAI antibody titer ≥ 1.40 1) antibody titers and 2) ex
vivo cellular immune response as surrogate correlates of protection. |
Substudie 1.
"IAMI-respons. Immunsvaret mot influensavaccin i en subpopulation av IAMI. "datum; 2018-08-24, version 2.0.
Det primära syftet är att fastställa vaccinsvar hos patienter med akut kranskärlssjukkdom genom att använda HAI-antikroppstiter ≥ 1,40 1)
antikroppstitrar och 2) immunrespons ex vivo som surrogat korrelerar med skydd. |
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E.3 | Principal 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) <40.
And:
- A finalized coronary angiography/PCI.
- Male or female subjects ≥18 years.
- Written informed consent.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
One year after vaccination
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E.5.2 | 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).
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E.5.2.1 | 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).
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LPLV
The sponsor reserves the right to terminate the study prematurely e.g. if study participant recruitment is too slow, if study participant retention in the study is insufficient or if undue risk related to the study intervention arises. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 8 |