Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes

Acute Coronary Syndrome Clinical Trial

— VIP-ACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001504
• Other study ID #: VIP-ACS trial
• Status: Completed
• Phase: Phase 3
• Start date: July 19, 2019
• Est. completion date: August 28, 2022

Study information

• Verified date: October 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1801
• Est. completion date: August 28, 2022
• Est. primary completion date: August 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Influenza, Human
• Syndrome

Intervention

Biological:
• Double Dose Quadrivalent Influenza Vaccine
Double Dose QIV (30µg Hemagglutinin)
• Standard Dose Quadrivalent Influenza Vaccine
Standard Dose QIV (15µg Hemagglutinin)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Solicited injection site and systemic events, unsolicited adverse events and serious adverse events following 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
Other	Safety overview after influenza vaccination until the end of the study.	Occurrence of unsolicited adverse events, including serious adverse events.	12 months
Primary	Hierarchical composite endpoint consisting of death, myocardial infarction, stroke, unstable angina hospitalization, heart failure hospitalization, urgent coronary revascularization or respiratory infections hospitalizations	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	Key Secondary End Point is a hierarchical outcome consisting only of cardiovascular death, myocardial infarction or stroke.	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
Secondary	Total mortality	Time to first occurrence of all cause death	12 months
Secondary	Cardiovascular mortality	Time to first occurrence of CV death	12 months
Secondary	Myocardial infarction	Time to first occurrence of myocardial infarction	12 months
Secondary	Unstable angina hospitalization	Time to first occurrence of Unstable angina hospitalization	12 months
Secondary	Stroke	Time to first occurrence of stroke	12 months
Secondary	TIA (Transient ischemic attack)	Time to first occurrence of TIA	12 months
Secondary	Heart failure hospitalizations	Time to first occurrence of Heart failure hospitalizations	12 months
Secondary	Respiratory infections hospitalizations	Time to first occurrence of hospitalization due to upper and lower respiratory tract infection (excluding COVID-19)	12 months
Secondary	Need for myocardial revascularization	Time to first occurrence of urgent coronary revascularization ischemia guide (urgent or not-urgent)	12 months
Secondary	Stent thrombosis	Time to first occurrence of probable and definite stent thrombosis	12 months
Secondary	COVID-19 hospitalizations	Time to first occurrence of COVID-19 hospitalizations	12 months