Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

Phase 3

Completed

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT04001504
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief 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.

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 Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Study First Posted: 2019-06-28
• Study Start: 2019-07-19
• Status Verified: 2021-10
• Primary Completion: 2022-08-28
• Study Completion: 2022-08-28
• Last Update Submitted: 2022-08-30
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1801

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations	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 Outcome Measures

Name	Time	Method
Stent thrombosis	12 months	Time to first occurrence of probable and definite stent thrombosis
TIA (Transient ischemic attack)	12 months	Time to first occurrence of TIA
Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.	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
Myocardial infarction	12 months	Time to first occurrence of myocardial infarction
Stroke	12 months	Time to first occurrence of stroke
Cardiovascular mortality	12 months	Time to first occurrence of CV death
Heart failure hospitalizations	12 months	Time to first occurrence of Heart failure hospitalizations
Respiratory infections hospitalizations	12 months	Time to first occurrence of hospitalization due to upper and lower respiratory tract infection (excluding COVID-19)
Need for myocardial revascularization	12 months	Time to first occurrence of urgent coronary revascularization ischemia guide (urgent or not-urgent)
Total mortality	12 months	Time to first occurrence of all cause death
Unstable angina hospitalization	12 months	Time to first occurrence of Unstable angina hospitalization
COVID-19 hospitalizations	12 months	Time to first occurrence of COVID-19 hospitalizations

Trial Locations

Locations (22)

Hospital e Clínica São Roque; 🇧🇷 Ipiaú, Bahia, Brazil

Hospital Ana Nery; 🇧🇷 Salvador, Bahia, Brazil

Hospital Cárdio Pulmonar; 🇧🇷 Salvador, Bahia, Brazil

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

Instituto de Cardiologia do Distrito Federal; 🇧🇷 Brasilia, DF, Brazil

Hospital Santa Lucia; 🇧🇷 Poços De Caldas, MG, Brazil

Hospital Universitário Ciências Médicas; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital Universitario da Universidade Estadual de Londrina; 🇧🇷 Londrina, Paraná, Brazil

Hospital Agamenon Magalhães; 🇧🇷 Recife, Pernambuco, Brazil

Pronto Socorro Cardiológico de Pernambuco; 🇧🇷 Recife, PE, Brazil

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