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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
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
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 efficiency 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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Biological: Double Dose Quadrivalent Influenza Vaccine Biological: Standard Dose Quadrivalent Influenza Vaccine Phase 3

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 of influenza vaccine in the hospital phase, when compared to usual dose vaccination (30 days hospital discharge), reduce the risk of major cardiovascular events (cardiovascular mortality, acute myocardial infarction and stroke) in patients with acute coronary syndrome.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. Major Cardiovascular Events (MACE) [ Time Frame: 12 months ]
    Cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke.


Secondary Outcome Measures :
  1. 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

  2. All-case mortality [ Time Frame: 12 months ]
    Time to first occurrence of all-cause mortality.

  3. Myocardial revascularization [ Time Frame: 12 months ]
    Occurrence of myocardial revascularization.

  4. Unstable angina hospitalization [ Time Frame: 12 months ]
    Occurrence of hospitalization due to unstable angina.

  5. Heart failure hospitalization [ Time Frame: 12 months ]
    Occurrence of hospitalization due to heart failure.

  6. Transient ischemic attack [ Time Frame: 12 months ]
    Occurrence of transient ischemia attack.

  7. Stent thrombosis [ Time Frame: 12 months ]
    Occurrence of probable and definite stent thrombosis.

  8. Upper and lower infection hospitalization [ Time Frame: 12 months ]
    Occurrence of hospitalization due to upper and lower respiratory tract infection.

  9. 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.


Other Outcome Measures:
  1. 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.

  2. Safety overview after influenza vaccination until the end of the study. [ Time Frame: 12 months ]
    Occurrence of unsolicited adverse events, including serious adverse events.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Henrique A Fonseca, PhD 55+ 11 21513725 henrique.fonseca@einstein.br
Contact: Vanessa Mazon 55+ 11 21513725 vanessa.mazon@einstein.br

Locations
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Brazil
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         
Sponsors and Collaborators
Hospital Israelita Albert Einstein
Ministry of Health, Brazil
Investigators
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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
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Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT04001504    
Other Study ID Numbers: VIP-ACS trial
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: December 20, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hospital Israelita Albert Einstein:
Unstable angina
Non-ST-Elevation Myocardial Infarction - NSTEMI
ST-Elevation Myocardial Infarction - STEMI
Quadrivalent Influenza Vaccine - QIV
Additional relevant MeSH terms:
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Influenza, Human
Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs