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出境医 / 临床实验 / Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes (VIP-ACS)
Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes (VIP-ACS)
Study Description
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.
Study Design
| 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 |
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures :
- Major Cardiovascular Events (MACE) [ Time Frame: 12 months ]Cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke.
Secondary Outcome Measures :
- 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.
Other Outcome Measures:
- 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.
Eligibility Criteria
| 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.
Contacts and Locations
Contacts
| Contact: Henrique A Fonseca, PhD | 55+ 11 21513725 | henrique.fonseca@einstein.br | |
| Contact: Vanessa Mazon | 55+ 11 21513725 | vanessa.mazon@einstein.br |
Locations
| 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
| 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 |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 26, 2019 | ||||||||
| First Posted Date ICMJE | June 28, 2019 | ||||||||
| Last Update Posted Date | September 3, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 19, 2019 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Major Cardiovascular Events (MACE) [ Time Frame: 12 months ] Cardiovascular mortality, non-fatal myocardial infarction (MI), or non-fatal stroke.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures |
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| Descriptive Information | |||||||||
| Brief Title ICMJE | Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes | ||||||||
| Official Title ICMJE | Evaluation of the Effectiveness of Double Dose Influenza Vaccination to Reduce Major Cardiovascular Events After an Acute Coronary Syndrome | ||||||||
| 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. | ||||||||
| 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. | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 3 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Acute Coronary Syndrome | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
9200 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2021 | ||||||||
| Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Brazil | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04001504 | ||||||||
| Other Study ID Numbers ICMJE | VIP-ACS trial | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Hospital Israelita Albert Einstein | ||||||||
| Study Sponsor ICMJE | Hospital Israelita Albert Einstein | ||||||||
| Collaborators ICMJE | Ministry of Health, Brazil | ||||||||
| Investigators ICMJE |
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| PRS Account | Hospital Israelita Albert Einstein | ||||||||
| Verification Date | August 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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