drugset / Trial / NCT04001504

Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

NCT04001504

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Quadrivalent influenza vaccine Vaccine 15 ug
Subject Quadrivalent influenza vaccine Vaccine 30 ug