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Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

NCT04001504 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1801

Last updated 2022-08-31

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndrome

Interventions

BIOLOGICAL

Double Dose Quadrivalent Influenza Vaccine

Double Dose QIV (30µg Hemagglutinin)

BIOLOGICAL

Standard Dose Quadrivalent Influenza Vaccine

Standard Dose QIV (15µg Hemagglutinin)

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Israelita Albert Einstein

    lead OTHER

Principal Investigators

  • Otávio Berwanger, MD-PhD · Academic Research Organization -- Hospital Israelita Albert Einstein

  • Henrique A Fonseca, PhD · Academic Research Organization -- Hospital Israelita Albert Einstein

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2022-08-28
Completion
2022-08-28

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001504 on ClinicalTrials.gov