Acute Coronary Syndrome
Conditions
Interventions
After informed consent, patients will be randomized 1: 1 to Influenza Vaccine or corresponding placebo under confidential allocation. The non-blinded study nurse in each center who is not protected or
Biological/vaccine
D26.660
Sponsors
Hospital Alemão Oswaldo Cruz
Hospital Alemão Oswaldo Cruz
Eligibility
Inclusion criteria
Inclusion criteria: Volunteers with 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 more or equal to 0.2 mV in leads V2-V3 and/or more or equal0.1 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 agravated 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 unstable angina defined as new or recently progressive angina symptoms; male or female subjects > 18 years; written informed consent.
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 FluQadri® 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 other similar trial (testing other types of vaccination which may interfere on clinical outcomes of the VIBE trial).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare outcome between the two randomized groups - Major Cardiovascular Events (MACE), defined by death, nonfatal AMI, nonfatal stroke, ischemia-guided myocardial revascularization, and hospitalization for unstable angina leading to 72-hour coronary intervention within 1 follow-up year | — |
Secondary
| Measure | Time frame |
|---|---|
| All-cause death ;Cardiovascular death;Non-fatal MI;Non-fatal Stroke (including transient ischemic attack);Stent thrombosis ;Coronary Revascularization (CABG and PCI);Hospitalization for heart failure;Cost-evaluation analysis | — |
Countries
Brazil
Contacts
Public ContactPriscila Kunitake
Hospital Alemão Oswaldo Cruz
Outcome results
None listed