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OpenTrials
Completed

NCT Number: NCT04001504

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

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.

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Key information

Conditions

Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Universidade Federal do Ceará / Hospital Universitário Walter Cantídio, Fortaleza, Ceará, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Dose Quadrivalent Influenza Vaccine

Biological

Double Dose QIV (30µg Hemagglutinin)

Standard Dose Quadrivalent Influenza Vaccine

Biological

Standard Dose QIV (15µg Hemagglutinin)

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

    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

Secondary outcomes

  1. 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

  2. Total mortality

    Time frame: 12 months

    Time to first occurrence of all cause death

  3. Cardiovascular mortality

    Time frame: 12 months

    Time to first occurrence of CV death

  4. Myocardial infarction

    Time frame: 12 months

    Time to first occurrence of myocardial infarction

  5. Unstable angina hospitalization

    Time frame: 12 months

    Time to first occurrence of Unstable angina hospitalization

  6. Stroke

    Time frame: 12 months

    Time to first occurrence of stroke

  7. TIA (Transient ischemic attack)

    Time frame: 12 months

    Time to first occurrence of TIA

  8. Heart failure hospitalizations

    Time frame: 12 months

    Time to first occurrence of Heart failure hospitalizations

  9. Respiratory infections hospitalizations

    Time frame: 12 months

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

  10. Need for myocardial revascularization

    Time frame: 12 months

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

  11. Stent thrombosis

    Time frame: 12 months

    Time to first occurrence of probable and definite stent thrombosis

  12. COVID-19 hospitalizations

    Time frame: 12 months

    Time to first occurrence of COVID-19 hospitalizations

Other outcomes

  1. 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.

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

    Time frame: 12 months

    Occurrence of unsolicited adverse events, including serious adverse events.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: VIP-ACS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 28, 2019
Registry last updated
Aug 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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