Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes (VIP-ACS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04001504|
Recruitment Status : Recruiting
First Posted : June 28, 2019
Last Update Posted : December 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Coronary Syndrome||Biological: Double Dose Quadrivalent Influenza Vaccine Biological: Standard Dose Quadrivalent Influenza Vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||9200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome|
|Actual Study Start Date :||July 19, 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: Double Dose Quadrivalent Influenza Vaccine
Double Dose QIV during index ACS hospitalization
Biological: Double Dose Quadrivalent Influenza Vaccine
Double Dose QIV (30µg Hemagglutinin)
Active Comparator: Standard Dose Quadrivalent Influenza Vaccine
Standard Dose QIV 30 days after hospital discharge
Biological: Standard Dose Quadrivalent Influenza Vaccine
Standard Dose QIV (15µg Hemagglutinin)
- Major Cardiovascular Events (MACE) [ Time Frame: 12 months ]Cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke.
- Time to first event (before control group vaccine effect): Cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke. [ Time Frame: 45 days ]Index hospitalization discharge to 45 day
- All-case mortality [ Time Frame: 12 months ]Time to first occurrence of all-cause mortality.
- Myocardial revascularization [ Time Frame: 12 months ]Occurrence of myocardial revascularization.
- Unstable angina hospitalization [ Time Frame: 12 months ]Occurrence of hospitalization due to unstable angina.
- Heart failure hospitalization [ Time Frame: 12 months ]Occurrence of hospitalization due to heart failure.
- Transient ischemic attack [ Time Frame: 12 months ]Occurrence of transient ischemia attack.
- Stent thrombosis [ Time Frame: 12 months ]Occurrence of probable and definite stent thrombosis.
- Upper and lower infection hospitalization [ Time Frame: 12 months ]Occurrence of hospitalization due to upper and lower respiratory tract infection.
- Renal outcome [ Time Frame: 12 months ]Defined as a 30% reduction in the glomerular filtration rate associated with an endpoint of <60 mL / min / 1.73m2 in patients without chronic kidney disease (glomerular filtration rate 60-90 mL / min / 1.73m2) at the beginning of the study. In patients with chronic kidney disease (<60 mL / min / 1.73m2) at the start of the study, renal outcome will be defined as a reduction in glomerular filtration rate or progression of renal disease to stage IV requiring dialysis or kidney transplantation.
- 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.
- Safety overview after influenza vaccination until the end of the study. [ Time Frame: 12 months ]Occurrence of unsolicited adverse events, including serious adverse events.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001504
|Contact: Henrique A Fonseca, PhD||55+ 11 email@example.com|
|Contact: Vanessa Mazon||55+ 11 firstname.lastname@example.org|
|Instituto de Cardiologia do Distrito Federal||Recruiting|
|Brasilia, DF, Brazil|
|Contact: Kenzo Fernandes|
|Principal Investigator: Diego M Mesquita, MD|
|Hospital Santa Lucia||Recruiting|
|Poços De Caldas, MG, Brazil|
|Contact: Gislayne Ribeiro|
|Principal Investigator: Frederico TC Dall'Orto, MD|
|Sub-Investigator: Ricardo Bergo, MD|
|Pronto Socorro Cardiológico de Pernambuco||Recruiting|
|Recife, PE, Brazil|
|Contact: Tarcya Patriota, MSc|
|Principal Investigator: Rodrigo P Pedrosa, MD-PhD|
|Sub-Investigator: Rodrigo L Patriota, MD|
|Instituto Estadual de Cardiologia Aloysio de Castro||Recruiting|
|Rio De Janeiro, RJ, Brazil|
|Contact: Simone R Souza|
|Principal Investigator: Aline S Villacorta, MD-PhD|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil|
|Contact: Mauren P Haeffner|
|Contact: Angelica Zanotto|
|Principal Investigator: Carisi A Polanczyk, MD-PhD|
|Sub-Investigator: Mariana V Vargas, MD-PhD|
|Faculdade de Medicina de Botucatu - UNESP||Recruiting|
|Botucatu, SP, Brazil|
|Contact: Carlos A Vieira|
|Contact: Nelmara Camargo|
|Principal Investigator: Marina P Okoshi, MD-PhD|
|Irmandade da Santa Casa de Misericórdia de Marília||Recruiting|
|Marília, SP, Brazil|
|Contact: Robson Alves|
|Principal Investigator: Pedro B Andrade, MD-PhD|
|Hospital Municipal "Dr. Fernando Mauro Pires da Rocha" - Hospital do Campo Limpo||Recruiting|
|São Paulo, SP, Brazil|
|Contact: Ludimila Souza|
|Contact: Lara Ceolin|
|Principal Investigator: Vinícus G Vitro, MD|
|Instituto do Coração - HC FMUSP||Recruiting|
|São Paulo, SP, Brazil|
|Contact: Natassja Huemer|
|Contact: Alexandra Vieira|
|Principal Investigator: Jose C Nicolau, MD-PhD|
|Sub-Investigator: Vanessa M Baldo, MD|
|Sub-Investigator: Talia F Dalçoquio, MD|
|Study Chair:||Otávio Berwanger, MD-PhD||Academic Research Organization -- Hospital Israelita Albert Einstein|
|Principal Investigator:||Henrique A Fonseca, PhD||Academic Research Organization -- Hospital Israelita Albert Einstein|