Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes (VIP-ACS)

August 30, 2022 updated by: Hospital Israelita Albert Einstein

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1801

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Instituto Dante Pazzanese
    • Bahia
      • Ipiaú, Bahia, Brazil
        • Hospital e Clínica São Roque
      • Salvador, Bahia, Brazil
        • Hospital Ana Nery
      • Salvador, Bahia, Brazil
        • Hospital Cardio Pulmonar
    • Ceará
      • Fortaleza, Ceará, Brazil
        • Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
    • DF
      • Brasilia, DF, Brazil
        • Instituto de Cardiologia do Distrito Federal
    • MG
      • Poços De Caldas, MG, Brazil
        • Hospital Santa Lucía
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil
        • Hospital Universitário Ciencias Medicas
    • PE
      • Recife, PE, Brazil
        • Pronto Socorro Cardiologico de Pernambuco
    • Paraná
      • Londrina, Paraná, Brazil
        • Hospital Universitário da Universidade Estadual de Londrina
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Hospital Agamenon Magalhães
    • RJ
      • Rio De Janeiro, RJ, Brazil
        • Instituto Estadual de Cardiologia Aloysio de Castro
    • RS
      • Porto Alegre, RS, Brazil
        • Hospital de Clinicas de Porto Alegre
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
        • Hospital Sao Lucas da PUCRS
    • SP
      • Botucatu, SP, Brazil
        • Faculdade de Medicina de Botucatu - UNESP
      • Marília, SP, Brazil
        • Irmandade da Santa Casa de Misericórdia de Marília
      • São Paulo, SP, Brazil
        • Instituto do Coração - HC FMUSP
    • Santa Catarina
      • Itajaí, Santa Catarina, Brazil
        • IPEMI - Instituto de Pesquisas Médicas de Itajaí
      • Joinville, Santa Catarina, Brazil
        • Hospital Dona Helena
      • Joinville, Santa Catarina, Brazil
        • Hospital Regional Hans Dieter Schmidt
    • Sergipe
      • Aracaju, Sergipe, Brazil
        • Centro de Pesquisa Clínica do Coração
    • São Paulo
      • Presidente Prudente, São Paulo, Brazil
        • Santa Casa de Misericórdia de Presidente Prudente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Double Dose Quadrivalent Influenza Vaccine
Double Dose QIV during index ACS hospitalization
Biological: Double Dose Quadrivalent Influenza Vaccine
Double Dose QIV (30µg Hemagglutinin)
Active Comparator: Standard Dose Quadrivalent Influenza Vaccine
Standard Dose QIV 30 days after randomization
Biological: Standard Dose Quadrivalent Influenza Vaccine
Standard Dose QIV (15µg Hemagglutinin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.
Time Frame: 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
12 months
Total mortality
Time Frame: 12 months
Time to first occurrence of all cause death
12 months
Cardiovascular mortality
Time Frame: 12 months
Time to first occurrence of CV death
12 months
Myocardial infarction
Time Frame: 12 months
Time to first occurrence of myocardial infarction
12 months
Unstable angina hospitalization
Time Frame: 12 months
Time to first occurrence of Unstable angina hospitalization
12 months
Stroke
Time Frame: 12 months
Time to first occurrence of stroke
12 months
TIA (Transient ischemic attack)
Time Frame: 12 months
Time to first occurrence of TIA
12 months
Heart failure hospitalizations
Time Frame: 12 months
Time to first occurrence of Heart failure hospitalizations
12 months
Respiratory infections hospitalizations
Time Frame: 12 months
Time to first occurrence of hospitalization due to upper and lower respiratory tract infection (excluding COVID-19)
12 months
Need for myocardial revascularization
Time Frame: 12 months
Time to first occurrence of urgent coronary revascularization ischemia guide (urgent or not-urgent)
12 months
Stent thrombosis
Time Frame: 12 months
Time to first occurrence of probable and definite stent thrombosis
12 months
COVID-19 hospitalizations
Time Frame: 12 months
Time to first occurrence of COVID-19 hospitalizations
12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Solicited injection site and systemic events, unsolicited adverse events and serious adverse events following vaccination.
Time Frame: Day 0 up to Day 7 post-vaccination
Occurrence of solicited injection site (Pain, Erythema, Swelling, Induration, and Bruising) and systemic reactions (Fever, Headache, Malaise, Myalgia, and Shivering) will be assessed in all participants.
Day 0 up to Day 7 post-vaccination
Safety overview after influenza vaccination until the end of the study.
Time Frame: 12 months
Occurrence of unsolicited adverse events, including serious adverse events.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Otávio Berwanger, MD-PhD, Academic Research Organization -- Hospital Israelita Albert Einstein
  • Principal Investigator: Henrique A Fonseca, PhD, Academic Research Organization -- Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VIP-ACS trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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