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Acute Coronary SyndromePhase 3VIP-ACSNCT04001504

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

A Phase 3 study testing Double Dose Quadrivalent Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine in people with Acute Coronary Syndrome, run by Hospital Israelita Albert Einstein at 22 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Double Dose Quadrivalent Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,801 participants
Where
22 sitesBrazil
Study dates
19 Jul 2019to 28 Aug 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

22 sites in 1 country.

22 sites in 1 country

Brazil22 sites

  • Centro de Pesquisa Clinica do Coração

    Aracaju, Sergipe

  • Hospital Universitário Ciências Médicas

    Belo Horizonte, Minas Gerais

  • Faculdade de Medicina de Botucatu - UNESP

    Botucatu, São Paulo

  • Instituto de Cardiologia do Distrito Federal

    Brasília, Federal District

  • Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

    Fortaleza, Ceará

  • Hospital e Clínica São Roque

    Ipiaú, Estado de Bahia

  • IPEMI - Instituto de Pesquisas Médicas de Itajaí

    Itajaí, Santa Catarina

  • Hospital Dona Helena

    Joinville, Santa Catarina

  • Hospital Regional Hans Dieter Schmidt

    Joinville, Santa Catarina

  • Hospital Universitario da Universidade Estadual de Londrina

    Londrina, Paraná

  • Irmandade da Santa Casa de Misericórdia de Marília

    Marília, São Paulo

  • Hospital Santa Lucia

    Poços de Caldas, Minas Gerais

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul

  • Santa Casa de Misericórdia de Presidente Prudente

    Presidente Prudente, São Paulo

  • Hospital Agamenon Magalhães

    Recife, Pernambuco

  • Pronto Socorro Cardiológico de Pernambuco

    Recife, Pernambuco

  • Instituto Estadual de Cardiologia Aloysio de Castro

    Rio de Janeiro, Rio de Janeiro

  • Hospital Ana Nery

    Salvador, Estado de Bahia

  • Hospital Cárdio Pulmonar

    Salvador, Estado de Bahia

  • Instituto do Coração - HC FMUSP

    São Paulo, São Paulo

  • Instituto Dante Pazzanese

    São Paulo

Other trials in Brazil

About this study

Official title: Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome

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.

Read the 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.

Being tested
Double Dose Quadrivalent Influenza Vaccine, Standard Dose Quadrivalent Influenza Vaccine
Keywords
Unstable angina, Non-ST-Elevation Myocardial Infarction - NSTEMI, ST-Elevation Myocardial Infarction - STEMI, Quadrivalent Influenza Vaccine - QIV
Medical subject headings
Acute Coronary Syndrome, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double Dose Quadrivalent Influenza VaccineBiological

    Double Dose QIV (30µg Hemagglutinin)

  • Standard Dose Quadrivalent Influenza VaccineBiological

    Standard Dose QIV (15µg Hemagglutinin)

Study groups in NCT04001504
Study groupRoleWhat they receive
Double Dose Quadrivalent Influenza VaccineExperimentalDouble Dose QIV during index ACS hospitalization
Receives: Biological: Double Dose Quadrivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza VaccineActive comparatorStandard Dose QIV 30 days after randomization
Receives: Biological: Standard Dose Quadrivalent Influenza Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (12)

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

    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

    Measured: 12 months

  2. Total mortality

    Time to first occurrence of all cause death

    Measured: 12 months

  3. Cardiovascular mortality

    Time to first occurrence of CV death

    Measured: 12 months

  4. Myocardial infarction

    Time to first occurrence of myocardial infarction

    Measured: 12 months

  5. Unstable angina hospitalization

    Time to first occurrence of Unstable angina hospitalization

    Measured: 12 months

  6. Stroke

    Time to first occurrence of stroke

    Measured: 12 months

  7. TIA (Transient ischemic attack)

    Time to first occurrence of TIA

    Measured: 12 months

  8. Heart failure hospitalizations

    Time to first occurrence of Heart failure hospitalizations

    Measured: 12 months

  9. Respiratory infections hospitalizations

    Time to first occurrence of hospitalization due to upper and lower respiratory tract infection (excluding COVID-19)

    Measured: 12 months

  10. Need for myocardial revascularization

    Time to first occurrence of urgent coronary revascularization ischemia guide (urgent or not-urgent)

    Measured: 12 months

  11. Stent thrombosis

    Time to first occurrence of probable and definite stent thrombosis

    Measured: 12 months

  12. COVID-19 hospitalizations

    Time to first occurrence of COVID-19 hospitalizations

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jun 2019
  2. Study start19 Jul 2019
  3. Primary completion28 Aug 2022
  4. Study completion28 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,801 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04001504
Sponsor's protocol ID
VIP-ACS trial
Acronym
VIP-ACS
Status last verified
Oct 2021
First submitted
26 Jun 2019
Last updated
31 Aug 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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. 2026 Apr;21(4):466-474. doi: 10.1177/17474930251383626. Epub 2025 Sep 19.

    PubMed 40973981

  • 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.

    PubMed 38154990

  • 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.

    PubMed 36030400

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Double Dose Quadrivalent Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine in people with Acute Coronary Syndrome, run by Hospital Israelita Albert Einstein at 22 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04001504, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2022.

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