Clinical trial NCT04001504: Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes
Official title: Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Keywords: Unstable angina
Non-ST-Elevation Myocardial Infarction - NSTEMI
ST-Elevation Myocardial Infarction - STEMI
Quadrivalent Influenza Vaccine - QIV
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2019-06-28
Enrollment: 1801
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

* Age \>= 18 years and older
* Acute coronary syndrome in hospital phase.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations
timeFrame: 12 months
Secondary outcomes:
measure: Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.
timeFrame: 12 months
measure: Total mortality
timeFrame: 12 months
measure: Cardiovascular mortality
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 12 months
measure: Unstable angina hospitalization
timeFrame: 12 months
measure: Stroke
timeFrame: 12 months
measure: TIA (Transient ischemic attack)
timeFrame: 12 months
measure: Heart failure hospitalizations
timeFrame: 12 months
measure: Respiratory infections hospitalizations
timeFrame: 12 months
measure: Need for myocardial revascularization
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
measure: COVID-19 hospitalizations
timeFrame: 12 months
Other outcomes:
measure: Solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination.
timeFrame: Day 0 up to Day 7 post-vaccination
measure: Safety overview after influenza vaccination until the end of the study.
timeFrame: 12 months
Locations:
city: Ipiaú
country: Brazil
facility: Hospital e Clínica São Roque
state: Bahia
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: Bahia
city: Salvador
country: Brazil
facility: Hospital Cárdio Pulmonar
state: Bahia
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
state: Ceará
city: Brasilia
country: Brazil
facility: Instituto de Cardiologia do Distrito Federal
state: DF
city: Poços De Caldas
country: Brazil
facility: Hospital Santa Lucia
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Universitário Ciências Médicas
state: Minas Gerais
city: Londrina
country: Brazil
facility: Hospital Universitario da Universidade Estadual de Londrina
state: Paraná
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhães
state: Pernambuco
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico de Pernambuco
state: PE
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Instituto Estadual de Cardiologia Aloysio de Castro
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Itajaí
country: Brazil
facility: IPEMI - Instituto de Pesquisas Médicas de Itajaí
state: Santa Catarina
city: Joinville
country: Brazil
facility: Hospital Dona Helena
state: Santa Catarina
city: Joinville
country: Brazil
facility: Hospital Regional Hans Dieter Schmidt
state: Santa Catarina
city: Aracaju
country: Brazil
facility: Centro de Pesquisa Clinica do Coração
state: Sergipe
city: Botucatu
country: Brazil
facility: Faculdade de Medicina de Botucatu - UNESP
state: SP
city: Marília
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Marília
state: SP
city: São Paulo
country: Brazil
facility: Instituto do Coração - HC FMUSP
state: SP
city: Presidente Prudente
country: Brazil
facility: Santa Casa de Misericórdia de Presidente Prudente
state: São Paulo
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese
Study officials:
affiliation: Academic Research Organization -- Hospital Israelita Albert Einstein
name: Otávio Berwanger, MD-PhD
role: STUDY_CHAIR
affiliation: Academic Research Organization -- Hospital Israelita Albert Einstein
name: Henrique A Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fonseca HAR, Furtado RHM, Zimerman A, Lemos PA, Franken M, Monfardini F, Pedrosa RP, Patriota RLS, Passos LCS, Dall'Orto FTC, Hoffmann Filho CR, Nascimento BR, Baldissera FA, Pereira CAC, Caramori PRA, de Andrade PB, Esteves C, Salim EF, da Silva JH, Pedro IC, Silva MCR, de Pedri EH, Carioca ACRD, de Piano LPA, Albuquerque CSN, Moia DDF, Momesso RGRAP, Machado FP, Damiani LP, Soares RVP, Schettino GP, Rizzo LV, Nicolau JC, Berwanger O. Influenza vaccination strategy in acute coronary syndromes: the VIP-ACS trial. Eur Heart J. 2022 Nov 1;43(41):4378-4388. doi: 10.1093/eurheartj/ehac472.