NCT04001504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,801

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2019

Typical duration for phase_3

Geographic Reach
1 country

22 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

July 19, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2022

Completed
Last Updated

August 31, 2022

Status Verified

October 1, 2021

Enrollment Period

3.1 years

First QC Date

June 26, 2019

Last Update Submit

August 30, 2022

Conditions

Acute Coronary Syndrome

Keywords

Unstable anginaNon-ST-Elevation Myocardial Infarction - NSTEMIST-Elevation Myocardial Infarction - STEMIQuadrivalent Influenza Vaccine - QIV

Outcome Measures

Primary Outcomes (1)

  • Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations

    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

    12 months

Secondary Outcomes (12)

  • Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.

    12 months

  • Total mortality

    12 months

  • Cardiovascular mortality

    12 months

  • Myocardial infarction

    12 months

  • Unstable angina hospitalization

    12 months

  • +7 more secondary outcomes

Other Outcomes (2)

  • Solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination.

    Day 0 up to Day 7 post-vaccination

  • Safety overview after influenza vaccination until the end of the study.

    12 months

Study Arms (2)

Double Dose Quadrivalent Influenza Vaccine

EXPERIMENTAL

Double Dose QIV during index ACS hospitalization

Biological: Double Dose Quadrivalent Influenza Vaccine

Standard Dose Quadrivalent Influenza Vaccine

ACTIVE COMPARATOR

Standard Dose QIV 30 days after randomization

Biological: Standard Dose Quadrivalent Influenza Vaccine

Interventions

Double Dose Quadrivalent Influenza VaccineBIOLOGICAL

Double Dose QIV (30µg Hemagglutinin)

Double Dose Quadrivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza VaccineBIOLOGICAL

Standard Dose QIV (15µg Hemagglutinin)

Standard Dose Quadrivalent Influenza Vaccine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • Breastfeeding women;
  • Pregnant women;
  • Presenting an acute coronary syndrome during months of December, January, and February.
  • Acute coronary syndrome hospitalization \>7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

Location

Hospital e Clínica São Roque

Ipiaú, Estado de Bahia, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Location

Hospital Cárdio Pulmonar

Salvador, Estado de Bahia, Brazil

Location

Instituto de Cardiologia do Distrito Federal

Brasília, Federal District, Brazil

Location

Hospital Universitário Ciências Médicas

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Location

Hospital Universitario da Universidade Estadual de Londrina

Londrina, Paraná, Brazil

Location

Hospital Agamenon Magalhães

Recife, Pernambuco, Brazil

Location

Pronto Socorro Cardiológico de Pernambuco

Recife, Pernambuco, Brazil

Location

Instituto Estadual de Cardiologia Aloysio de Castro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

IPEMI - Instituto de Pesquisas Médicas de Itajaí

Itajaí, Santa Catarina, Brazil

Location

Hospital Dona Helena

Joinville, Santa Catarina, Brazil

Location

Hospital Regional Hans Dieter Schmidt

Joinville, Santa Catarina, Brazil

Location

Centro de Pesquisa Clinica do Coração

Aracaju, Sergipe, Brazil

Location

Faculdade de Medicina de Botucatu - UNESP

Botucatu, São Paulo, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Marília

Marília, São Paulo, Brazil

Location

Santa Casa de Misericórdia de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

Location

Instituto do Coração - HC FMUSP

São Paulo, São Paulo, Brazil

Location

Instituto Dante Pazzanese

São Paulo, Brazil

Location

Related Publications (3)

  • Fonseca HAR, Sampaio Silva G, Monfardini F, Nicolau JC, Rizzo LV, Berwanger O. Influenza vaccination for prevention of death and major cardiovascular events in patients with a history of stroke: A subanalysis of the VIP-ACS trial. Int J Stroke. 2025 Sep 19:17474930251383626. doi: 10.1177/17474930251383626. Online ahead of print.

    PMID: 40973981DERIVED

  • Fonseca HAR, Zimerman A, Monfardini F, Guimaraes HP, Pedrosa RP, Patriota RLS, Couto Patriota TLG, Passos LCS, Dall'Orto FTC, Hoffmann Filho CR, Nascimento BR, Baldissera FA, Pereira CAC, Caramori PRA, Andrade PB, Okoshi MP, Polanczyk CA, Silveira FS, Villacorta AS, Nicolau JC, Rizzo LV, Berwanger O; VIP-ACS team. In-Hospital influenza vaccination to prevent cardiorespiratory events in the first 45 days after acute coronary syndrome: A prespecified analysis of the VIP-ACS trial. Vaccine. 2024 Jan 25;42(3):496-504. doi: 10.1016/j.vaccine.2023.12.074. Epub 2023 Dec 27.

    PMID: 38154990DERIVED

  • 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.

    PMID: 36030400DERIVED

MeSH Terms

Conditions

Acute Coronary SyndromeAngina, Unstable

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Otávio Berwanger, MD-PhD

    Academic Research Organization -- Hospital Israelita Albert Einstein

    STUDY CHAIR

  • Henrique A Fonseca, PhD

    Academic Research Organization -- Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2019

First Posted

June 28, 2019

Study Start

July 19, 2019

Primary Completion

August 28, 2022

Study Completion

August 28, 2022

Last Updated

August 31, 2022

Record last verified: 2021-10

Locations

BR(22)