TY - JOUR
T1 - Ticagrelor versus clopidogrel after fibrinolytic therapy in patients with ST-elevation myocardial infarction
T2 - Rationale and design of the ticagrelor in patients with ST elevation myocardial infarction treated with thrombolysis (TREAT) trial
AU - Berwanger, Otavio
AU - Nicolau, Jose C.
AU - Carvalho, Antonio C.
AU - Jiang, Lixin
AU - Goodman, Shaun
AU - Nicholls, Stephen J.
AU - Parkhomenko, Alexander
AU - Averkov, Oleg
AU - Tajer, Carlos
AU - Malaga, Germán
AU - Kerr Saraiva, Jose F.
AU - Fonseca, Francisco
AU - Guimaraes, Helio P.
AU - de Barros e Silva, Pedro G.M.
AU - Damiani, Lucas P.
AU - Paisani, Denise M.
AU - Lasagno, Camila M.R.
AU - Candido, Carolina T.
AU - Valeis, Nanci
AU - Moia, Diogo D.F.
AU - Piegas, Leopoldo S.
AU - Granger, Christopher B.
AU - White, Harvey
AU - Lopes, Renato D.
N1 - Funding Information:
PGMBS: Research support from AstraZeneca, Sanofi, Pfizer, Bayer, and fees and honoraria from Boehringer Ingelheim and Daiichi Sankyo
Funding Information:
SGG: reports receiving research grant support and/or speaker/consulting honoraria from AstraZeneca, Amgen, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Tenax Therapeutics.
Funding Information:
JFKS: reports receiving contracted consulting fees and travel support from Amgen,Jansen, Novo Nordisk, Eli Lilly, AstraZeneca, Novartis, Sanofi-Aventis, Boehringer Ingelheim, grant support from Amgen, Eli Lilly, AstraZeneca, Jansen, Novo Nordisk, Novartis, Boehringer Ingelheim, boards of the AstraZeneca, Boehringer Ingelheim, Novartis, Novo Nordisk.
Funding Information:
HDW: Dr White has received research grants from Sanofi-Aventis, Eli Lilly, National Institute of Health, George Institute, Omthera Pharmaceuticals, Pfizer New Zealand, Intarcia Therapeutics Inc., Elsai Inc., Dalcor Pharma UK Inc. and Honoraria and non-financial support from AstraZeneca, Advisory Boards for Sirtex and Acetilion.
Funding Information:
RDL: Research support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer; Consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola.
PY - 2018/8
Y1 - 2018/8
N2 - Background: The safety and efficacy of ticagrelor in patients with ST-elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remain uncertain. Objectives: The primary objective of the TicagRElor in pAtients with ST elevation myocardial infarction treated with Thrombolysis (TREAT) trial is to evaluate the short-term safety of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. Key secondary objectives are to assess the safety and efficacy of ticagrelor compared with clopidogrel at 12-months. Design: The TREAT trial is a multicenter, randomized, phase III, Prospective randomized open blinded end-point (PROBE) study that enrolled 3,799 patients in 152 sites from 10 countries. Following administration of fibrinolytic therapy patients were randomized to a loading dose of ticagrelor 180 mg or clopidogrel 300 mg followed by a maintenance dose of ticagrelor 90 mg twice daily or clopidogrel 75 mg/day for 12-months. The primary outcome is the rate of TIMI major bleeding at 30-days and will be assessed for non-inferiority using an intention-to-treat analysis. Co-treatments include aspirin and anticoagulants. Other evidence based therapies are also recommended. Secondary efficacy outcome include a composite of death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack or other arterial thrombotic event. All-cause mortality as well as individual components of the combined efficacy endpoint will also be ascertained. TREAT is an international randomized controlled trial comparing ticagrelor with clopidogrel in STEMI patients treated with fibrinolytic therapy. The results of this trial will inform clinical practice and international guidelines.
AB - Background: The safety and efficacy of ticagrelor in patients with ST-elevation myocardial infarction (STEMI) treated with fibrinolytic therapy remain uncertain. Objectives: The primary objective of the TicagRElor in pAtients with ST elevation myocardial infarction treated with Thrombolysis (TREAT) trial is to evaluate the short-term safety of ticagrelor when compared with clopidogrel in STEMI patients treated with fibrinolytic therapy. Key secondary objectives are to assess the safety and efficacy of ticagrelor compared with clopidogrel at 12-months. Design: The TREAT trial is a multicenter, randomized, phase III, Prospective randomized open blinded end-point (PROBE) study that enrolled 3,799 patients in 152 sites from 10 countries. Following administration of fibrinolytic therapy patients were randomized to a loading dose of ticagrelor 180 mg or clopidogrel 300 mg followed by a maintenance dose of ticagrelor 90 mg twice daily or clopidogrel 75 mg/day for 12-months. The primary outcome is the rate of TIMI major bleeding at 30-days and will be assessed for non-inferiority using an intention-to-treat analysis. Co-treatments include aspirin and anticoagulants. Other evidence based therapies are also recommended. Secondary efficacy outcome include a composite of death from vascular causes, myocardial infarction, stroke, severe recurrent ischemia, transient ischemic attack or other arterial thrombotic event. All-cause mortality as well as individual components of the combined efficacy endpoint will also be ascertained. TREAT is an international randomized controlled trial comparing ticagrelor with clopidogrel in STEMI patients treated with fibrinolytic therapy. The results of this trial will inform clinical practice and international guidelines.
UR - http://www.scopus.com/inward/record.url?scp=85048718068&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2018.02.017
DO - 10.1016/j.ahj.2018.02.017
M3 - Article
AN - SCOPUS:85048718068
VL - 202
SP - 89
EP - 96
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -