Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes
- Conditions
- Acute Coronary Syndrome
- Interventions
- Biological: Double Dose Quadrivalent Influenza VaccineBiological: Standard Dose Quadrivalent Influenza Vaccine
- Registration Number
- NCT04001504
- Lead Sponsor
- Hospital Israelita Albert Einstein
- Brief Summary
Cardiovascular disease has a great burden in the context of public health, as well as the low pharmacological adherence of patients who have chronic non-transmissible diseases. However, the investigators do not have data on the efficacy of vaccination to reduce cardiovascular events in the acute coronary syndromes, and the few studies evaluating the cardioprotective potential of the influenza vaccine were conducted in countries with well defined seasonalities, divergent of Brazil, that presents a constant viral circulation during all months of the year and distinct among its regions. Therefore, study evaluating higher dose vaccination in a period that contemplates the seasonality of the influenza virus in Brazil may bring important findings to different scientific gaps, as well as clarify questions about the possible benefit of doubled vaccination - which does not present contraindications - immediately after a atherothrombotic event. If it shows real benefit, it could also be a future therapeutic tool adjuvant to traditional drug therapy in the prevention of cardiovascular events.
- Detailed Description
Phase III, randomized, controlled, multicenter, open-label, superiority, 1:1 allocation, blind assessment of clinical outcomes and intention-to-treat analysis clinical trial to determine whether increased doses(double dose) of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days of randomization), decreases the risk of cardiovascular and respiratory events. Hospitalizations due to COVID-19 are excluded from the respiratory infection component of the primary outcome.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1801
Not provided
- Participation in another clinical trial with vaccines;
- Refusal to provide consent;
- Hypersensitivity and/or anaphylaxis to any component of the vaccine, or Guillain-Barré within 6 weeks after previous influenza vaccine;
- Have already received the influenza vaccine with the same strains used in the study within the last 12 months of inclusion in the study
- Breastfeeding women;
- Pregnant women;
- Presenting an acute coronary syndrome during months of December, January, and February.
- Acute coronary syndrome hospitalization >7 days
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Double Dose Quadrivalent Influenza Vaccine Double Dose Quadrivalent Influenza Vaccine Double Dose QIV during index ACS hospitalization Standard Dose Quadrivalent Influenza Vaccine Standard Dose Quadrivalent Influenza Vaccine Standard Dose QIV 30 days after randomization
- Primary Outcome Measures
Name Time Method Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations 12 months The primary objective will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner
- Secondary Outcome Measures
Name Time Method COVID-19 hospitalizations 12 months Time to first occurrence of COVID-19 hospitalizations
Stent thrombosis 12 months Time to first occurrence of probable and definite stent thrombosis
TIA (Transient ischemic attack) 12 months Time to first occurrence of TIA
Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke. 12 months The key secondary end point will be analyzed using the win ratio approach comparing every participant of treatment group to every participant of control group to determine a winner
Myocardial infarction 12 months Time to first occurrence of myocardial infarction
Stroke 12 months Time to first occurrence of stroke
Cardiovascular mortality 12 months Time to first occurrence of CV death
Heart failure hospitalizations 12 months Time to first occurrence of Heart failure hospitalizations
Respiratory infections hospitalizations 12 months Time to first occurrence of hospitalization due to upper and lower respiratory tract infection (excluding COVID-19)
Need for myocardial revascularization 12 months Time to first occurrence of urgent coronary revascularization ischemia guide (urgent or not-urgent)
Total mortality 12 months Time to first occurrence of all cause death
Unstable angina hospitalization 12 months Time to first occurrence of Unstable angina hospitalization
Trial Locations
- Locations (22)
Santa Casa de Misericórdia de Presidente Prudente
🇧🇷Presidente Prudente, São Paulo, Brazil
Hospital Santa Lucia
🇧🇷Poços De Caldas, MG, Brazil
Hospital Agamenon Magalhães
🇧🇷Recife, Pernambuco, Brazil
Hospital São Lucas da PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto do Coração - HC FMUSP
🇧🇷São Paulo, SP, Brazil
Hospital Universitário Ciências Médicas
🇧🇷Belo Horizonte, Minas Gerais, Brazil
Hospital Cárdio Pulmonar
🇧🇷Salvador, Bahia, Brazil
Hospital e Clínica São Roque
🇧🇷Ipiaú, Bahia, Brazil
Hospital Ana Nery
🇧🇷Salvador, Bahia, Brazil
Instituto de Cardiologia do Distrito Federal
🇧🇷Brasilia, DF, Brazil
Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
🇧🇷Fortaleza, Ceará, Brazil
Hospital Universitario da Universidade Estadual de Londrina
🇧🇷Londrina, Paraná, Brazil
Pronto Socorro Cardiológico de Pernambuco
🇧🇷Recife, PE, Brazil
Instituto Estadual de Cardiologia Aloysio de Castro
🇧🇷Rio De Janeiro, RJ, Brazil
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
IPEMI - Instituto de Pesquisas Médicas de Itajaí
🇧🇷Itajaí, Santa Catarina, Brazil
Hospital Dona Helena
🇧🇷Joinville, Santa Catarina, Brazil
Hospital Regional Hans Dieter Schmidt
🇧🇷Joinville, Santa Catarina, Brazil
Irmandade da Santa Casa de Misericórdia de Marília
🇧🇷Marília, SP, Brazil
Faculdade de Medicina de Botucatu - UNESP
🇧🇷Botucatu, SP, Brazil
Instituto Dante Pazzanese
🇧🇷São Paulo, Brazil
Centro de Pesquisa Clinica do Coração
🇧🇷Aracaju, Sergipe, Brazil