Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial

Detalhes bibliográficos
Autor(a) principal: Fonseca, Francisco A. H. [UNIFESP]
Data de Publicação: 2017
Outros Autores: Izar, Maria Cristina [UNIFESP], Maugeri, Ieda M. L. [UNIFESP], Berwanger, Otavio, Damiani, Lucas P., Pinto, Ibraim M., Szarf, Gilberto [UNIFESP], Franca, Carolina N., Bianco, Henrique T. [UNIFESP], Moreira, Flavio T. [UNIFESP], Caixeta, Adriano [UNIFESP], Alves, Claudia M. R. [UNIFESP], Lopes, Aline Soriano [UNIFESP], Klassen, Aline [UNIFESP], Tavares, Marina F. M., Fonseca, Henrique A. [UNIFESP], Carvalho, Antonio C. C. [UNIFESP]
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNIFESP
Texto Completo: http://dx.doi.org/10.1186/s13063-017-2361-1
https://repositorio.unifesp.br/handle/11600/53987
Resumo: Background: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. Methods/design: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months. The trial will also evaluate the improvement in the immune/inflammatory responses mediated by B and T lymphocytes. Omics field (metabolomics and proteomics) will help to understand these responses by molecular events. Discussion: BATTLE-AMI is aimed to (1) evaluate the role of subsets of lymphocytes on microcirculation improvement and (2) show how the choice of statin/antiplatelet therapy may affect cardiac remodeling after acute myocardial infarction with ST elevation.
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spelling Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trialBackground: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. Methods/design: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months. The trial will also evaluate the improvement in the immune/inflammatory responses mediated by B and T lymphocytes. Omics field (metabolomics and proteomics) will help to understand these responses by molecular events. Discussion: BATTLE-AMI is aimed to (1) evaluate the role of subsets of lymphocytes on microcirculation improvement and (2) show how the choice of statin/antiplatelet therapy may affect cardiac remodeling after acute myocardial infarction with ST elevation.Univ Fed Sao Paulo, Rua Loefgren 1350, BR-04040001 Sao Paulo, SP, BrazilHosp Coracao, Rua Desembargador Eliseu Guilherme,147, Sao Paulo, BrazilInst Dante Pazzanese Cardiol, Ave Dante Pazzanese 500, Sao Paulo, BrazilUniv Santo Amaro, Rua Prof Eneas de Siqueira 340, Sao Paulo, BrazilUniv Sao Paulo, Ave Prof Lineu Prestes,748, Sao Paulo, BrazilUniv Fed Sao Paulo, Rua Loefgren 1350, BR-04040001 Sao Paulo, SP, BrazilWeb of ScienceSao Paulo Research Foundation, Sao Paulo, Brazil [FAPESP 2012/51692-7]AstraZeneca [ESR 14-10726]FAPESP 2012/51692-7Biomed Central Ltd2020-07-02T18:52:15Z2020-07-02T18:52:15Z2017info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion-application/pdfhttp://dx.doi.org/10.1186/s13063-017-2361-1Trials. London, v. 18, p. -, 2017.10.1186/s13063-017-2361-1WOS000418652400002.pdf1745-6215https://repositorio.unifesp.br/handle/11600/53987WOS:000418652400002engTrialsLondoninfo:eu-repo/semantics/openAccessFonseca, Francisco A. H. [UNIFESP]Izar, Maria Cristina [UNIFESP]Maugeri, Ieda M. L. [UNIFESP]Berwanger, OtavioDamiani, Lucas P.Pinto, Ibraim M.Szarf, Gilberto [UNIFESP]Franca, Carolina N.Bianco, Henrique T. [UNIFESP]Moreira, Flavio T. [UNIFESP]Caixeta, Adriano [UNIFESP]Alves, Claudia M. R. [UNIFESP]Lopes, Aline Soriano [UNIFESP]Klassen, Aline [UNIFESP]Tavares, Marina F. M.Fonseca, Henrique A. [UNIFESP]Carvalho, Antonio C. C. [UNIFESP]reponame:Repositório Institucional da UNIFESPinstname:Universidade Federal de São Paulo (UNIFESP)instacron:UNIFESP2024-08-03T05:20:25Zoai:repositorio.unifesp.br/:11600/53987Repositório InstitucionalPUBhttp://www.repositorio.unifesp.br/oai/requestbiblioteca.csp@unifesp.bropendoar:34652024-08-03T05:20:25Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)false
dc.title.none.fl_str_mv Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
title Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
spellingShingle Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
Fonseca, Francisco A. H. [UNIFESP]
title_short Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
title_full Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
title_fullStr Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
title_full_unstemmed Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
title_sort Effects of four antiplatelet/statin combined strategies on immune and inflammatory responses in patients with acute myocardial infarction undergoing pharmacoinvasive strategy: Design and rationale of the B and T Types of Lymphocytes Evaluation in Acute Myocardial Infarction (BATTLE-AMI) study: study protocol for a randomized controlled trial
author Fonseca, Francisco A. H. [UNIFESP]
author_facet Fonseca, Francisco A. H. [UNIFESP]
Izar, Maria Cristina [UNIFESP]
Maugeri, Ieda M. L. [UNIFESP]
Berwanger, Otavio
Damiani, Lucas P.
Pinto, Ibraim M.
Szarf, Gilberto [UNIFESP]
Franca, Carolina N.
Bianco, Henrique T. [UNIFESP]
Moreira, Flavio T. [UNIFESP]
Caixeta, Adriano [UNIFESP]
Alves, Claudia M. R. [UNIFESP]
Lopes, Aline Soriano [UNIFESP]
Klassen, Aline [UNIFESP]
Tavares, Marina F. M.
Fonseca, Henrique A. [UNIFESP]
Carvalho, Antonio C. C. [UNIFESP]
author_role author
author2 Izar, Maria Cristina [UNIFESP]
Maugeri, Ieda M. L. [UNIFESP]
Berwanger, Otavio
Damiani, Lucas P.
Pinto, Ibraim M.
Szarf, Gilberto [UNIFESP]
Franca, Carolina N.
Bianco, Henrique T. [UNIFESP]
Moreira, Flavio T. [UNIFESP]
Caixeta, Adriano [UNIFESP]
Alves, Claudia M. R. [UNIFESP]
Lopes, Aline Soriano [UNIFESP]
Klassen, Aline [UNIFESP]
Tavares, Marina F. M.
Fonseca, Henrique A. [UNIFESP]
Carvalho, Antonio C. C. [UNIFESP]
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Fonseca, Francisco A. H. [UNIFESP]
Izar, Maria Cristina [UNIFESP]
Maugeri, Ieda M. L. [UNIFESP]
Berwanger, Otavio
Damiani, Lucas P.
Pinto, Ibraim M.
Szarf, Gilberto [UNIFESP]
Franca, Carolina N.
Bianco, Henrique T. [UNIFESP]
Moreira, Flavio T. [UNIFESP]
Caixeta, Adriano [UNIFESP]
Alves, Claudia M. R. [UNIFESP]
Lopes, Aline Soriano [UNIFESP]
Klassen, Aline [UNIFESP]
Tavares, Marina F. M.
Fonseca, Henrique A. [UNIFESP]
Carvalho, Antonio C. C. [UNIFESP]
description Background: Early reperfusion of the occluded coronary artery during acute myocardial infarction is considered crucial for reduction of infarcted mass and recovery of ventricular function. Effective microcirculation and the balance between protective and harmful lymphocytes may have roles in reperfusion injury and may affect final ventricular remodeling. Methods/design: BATTLE-AMI is an open-label, randomized trial comparing the effects of four therapeutic strategies (rosuvastatin/ticagrelor, rosuvastatin/clopidogrel, simvastatin plus ezetimibe/ticagrelor, or simvastatin plus ezetimibe/clopidogrel) on infarcted mass and left ventricular ejection fraction (LVEF) (blinded endpoints) in patients with ST-segment elevation myocardial infarction submitted to fibrinolytic therapy before coronary angiogram (pharmacoinvasive strategy). All patients (n = 300, 75 per arm) will be followed up for six months. The effects of treatment on subsets of B and T lymphocytes will be determined by flow-cytometry/ELISPOT and will be correlated with the infarcted mass, LVEF, and microcirculation perfusion obtained by cardiac magnetic resonance imaging. The primary hypothesis is that the combined rosuvastatin/ticagrelor therapy will be superior to other therapies (particularly for the comparison with simvastatin plus ezetimibe/clopidogrel) for the achievement of better LVEF at 30 days (primary endpoint) and smaller infarcted mass (secondary endpoint) at 30 days and six months. The trial will also evaluate the improvement in the immune/inflammatory responses mediated by B and T lymphocytes. Omics field (metabolomics and proteomics) will help to understand these responses by molecular events. Discussion: BATTLE-AMI is aimed to (1) evaluate the role of subsets of lymphocytes on microcirculation improvement and (2) show how the choice of statin/antiplatelet therapy may affect cardiac remodeling after acute myocardial infarction with ST elevation.
publishDate 2017
dc.date.none.fl_str_mv 2017
2020-07-02T18:52:15Z
2020-07-02T18:52:15Z
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1186/s13063-017-2361-1
Trials. London, v. 18, p. -, 2017.
10.1186/s13063-017-2361-1
WOS000418652400002.pdf
1745-6215
https://repositorio.unifesp.br/handle/11600/53987
WOS:000418652400002
url http://dx.doi.org/10.1186/s13063-017-2361-1
https://repositorio.unifesp.br/handle/11600/53987
identifier_str_mv Trials. London, v. 18, p. -, 2017.
10.1186/s13063-017-2361-1
WOS000418652400002.pdf
1745-6215
WOS:000418652400002
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv Trials
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eu_rights_str_mv openAccess
dc.format.none.fl_str_mv -
application/pdf
dc.coverage.none.fl_str_mv London
dc.publisher.none.fl_str_mv Biomed Central Ltd
publisher.none.fl_str_mv Biomed Central Ltd
dc.source.none.fl_str_mv reponame:Repositório Institucional da UNIFESP
instname:Universidade Federal de São Paulo (UNIFESP)
instacron:UNIFESP
instname_str Universidade Federal de São Paulo (UNIFESP)
instacron_str UNIFESP
institution UNIFESP
reponame_str Repositório Institucional da UNIFESP
collection Repositório Institucional da UNIFESP
repository.name.fl_str_mv Repositório Institucional da UNIFESP - Universidade Federal de São Paulo (UNIFESP)
repository.mail.fl_str_mv biblioteca.csp@unifesp.br
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