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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

Authors: Francisco A. H. Fonseca, Maria Cristina Izar, Ieda M. L. Maugeri, Otavio Berwanger, Lucas P. Damiani, Ibraim M. Pinto, Gilberto Szarf, Carolina N. França, Henrique T. Bianco, Flavio T. Moreira, Adriano Caixeta, Claudia M. R. Alves, Aline Soriano Lopes, Aline Klassen, Marina F. M. Tavares, Henrique A. Fonseca, Antonio C. C. Carvalho, for the BATTLE-AMI Investigators

Published in: Trials | Issue 1/2017

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Abstract

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.

Trial registration

ClinicalTrials.gov, NCT02428374. Registered on 28 September 2014.
Appendix
Available only for authorised users
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Metadata
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
Authors
Francisco A. H. Fonseca
Maria Cristina Izar
Ieda M. L. Maugeri
Otavio Berwanger
Lucas P. Damiani
Ibraim M. Pinto
Gilberto Szarf
Carolina N. França
Henrique T. Bianco
Flavio T. Moreira
Adriano Caixeta
Claudia M. R. Alves
Aline Soriano Lopes
Aline Klassen
Marina F. M. Tavares
Henrique A. Fonseca
Antonio C. C. Carvalho
for the BATTLE-AMI Investigators
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2361-1

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