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(s):Show less -

Fonseca, Francisco A. H. ^[1] ; Izar, Maria Cristina ^[1] ; Maugeri, Ieda M. L. ^[1] ; Berwanger, Otavio ^[2] ; Damiani, Lucas P. ^[2] ; Pinto, Ibraim M. ^[3] ; Szarf, Gilberto ^[1] ; Franca, Carolina N. ^[4] ; Bianco, Henrique T. ^[1] ; Moreira, Flavio T. ^[1] ; Caixeta, Adriano ^[1] ; Alves, Claudia M. R. ^[1] ; Lopes, Aline Soriano ^[1] ; Klassen, Aline ^[1] ; Tavares, Marina F. M. ^[5] ; Fonseca, Henrique A. ^[1] ; Carvalho, Antonio C. C. ^[1] ; Investigators, BATTLE-AMI

Affiliation

^[1] Univ Fed Sao Paulo, Rua Loefgren 1350, BR-04040001 Sao Paulo, SP - Brazil

^[2] Hosp Coracao, Rua Desembargador Eliseu Guilherme, 147, Sao Paulo - Brazil

^[3] Inst Dante Pazzanese Cardiol, Ave Dante Pazzanese 500, Sao Paulo - Brazil

^[4] Univ Santo Amaro, Rua Prof Eneas de Siqueira 340, Sao Paulo - Brazil

^[5] Univ Sao Paulo, Ave Prof Lineu Prestes, 748, Sao Paulo - Brazil

• Document type: Journal article
• Source: Trials; v. 18, DEC 19 2017.
• Web of Science Citations: 3

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. (AU)

• FAPESP's process: 12/51692-7 - Role of adaptative immunity on the progress of ischemic heart disease after acute myocardial infarction
• Grantee: Francisco Antonio Helfenstein Fonseca
• Support Opportunities: Research Projects - Thematic Grants