Jacek Kubica1, Piotr Adamski1, Katarzyna Buszko1, Malwina Barańska1, Joanna Sikora1, Michał Piotr Marszałł1, Przemysław Sobczak1, Adam Sikora1, Wiktor Kuliczkowski2, Tomasz Fabiszak1, Aldona Kubica1, Bernd Jilma3, Dimitrios Alexopoulos4, Eliano Pio Navarese1,5,6,7. 1. Collegium Medicum, Nicolaus Copernicus University, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland. 2. Department and Clinic of Cardiology, Wrocław Medical University, 213 Borowska Street, Wroclaw 50-556, Poland. 3. Department of Clinical Pharmacology, Medical University of Vienna, Waehringer Guertel 18-20, Vienna 1090, Austria. 4. 2nd Department of Cardiology, National and Capodistrian University of Athens, Attikon University Hospital, Rimini 1, Athens 12462, Greece. 5. Interventional Cardiology and Cardiovascular Medicine Research, Cardiovascular Research Center, Mater Dei Hospital, Samuel F Hahnemann, 10, 70125 Bari, Italy. 6. SIRIO MEDICINE network, 13-15 Jagiellońska Street, 85-067 Bydgoszcz, Poland. 7. Faculty of Medicine, University of Alberta, 8440 112 St. NW, Edmonton, Alberta T6G 2R7, Canada.
Abstract
AIMS: Currently available data indicate that reduction of ticagrelor maintenance dose (MD) 1-3 years after acute myocardial infarction (AMI) not only provides sufficient platelet inhibition but also can improve ticagrelor's safety profile. The aim of this study was to compare the antiplatelet effect of reduced and standard ticagrelor MD in stable patients beginning 1 month after AMI. METHODS AND RESULTS: In a single-centre, randomized, open-label, active-controlled trial, on Day 30 following AMI, 52 patients (26 in each study arm) were assigned in a 1:1 ratio to receive either reduced (60 mg b.i.d) or standard (90 mg b.i.d) ticagrelor MD for the following 2 weeks. On Day 45 after AMI the antiplatelet effect of ticagrelor was evaluated with the VASP assay and Multiplate, and there were no significant differences in platelet inhibition between patients on reduced vs. standard MD [VASP: 10.4 (5.6-22.2) vs. 14.1 (9.4-22.1) platelet reactivity index; P = 0.30; Multiplate: 30.0 (24.0-39.0) vs. 26.5 (22.0-35.0) U; P = 0.26]. Likewise, no differences were found regarding the prevalence of on-ticagrelor high platelet reactivity between patients on ticagrelor 60 mg b.i.d vs. 90 mg b.i.d (VASP: 4% vs. 8%; P = 0.67; Multiplate: 15% vs. 8%; P = 0.54). Administration of reduced MD resulted in proportionally lower plasma concentrations of ticagrelor and its active metabolite on Day 45 after AMI. CONCLUSION: These results suggest that lowering ticagrelor MD 1 month after AMI confers an adequate antiplatelet effect that is comparable to the standard dose. The tested strategy warrants further research to assess its clinical efficacy and safety. CLINICALTRIALS.GOV IDENTIFIER: NCT03251859. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: Currently available data indicate that reduction of ticagrelor maintenance dose (MD) 1-3 years after acute myocardial infarction (AMI) not only provides sufficient platelet inhibition but also can improve ticagrelor's safety profile. The aim of this study was to compare the antiplatelet effect of reduced and standard ticagrelor MD in stable patients beginning 1 month after AMI. METHODS AND RESULTS: In a single-centre, randomized, open-label, active-controlled trial, on Day 30 following AMI, 52 patients (26 in each study arm) were assigned in a 1:1 ratio to receive either reduced (60 mg b.i.d) or standard (90 mg b.i.d) ticagrelor MD for the following 2 weeks. On Day 45 after AMI the antiplatelet effect of ticagrelor was evaluated with the VASP assay and Multiplate, and there were no significant differences in platelet inhibition between patients on reduced vs. standard MD [VASP: 10.4 (5.6-22.2) vs. 14.1 (9.4-22.1) platelet reactivity index; P = 0.30; Multiplate: 30.0 (24.0-39.0) vs. 26.5 (22.0-35.0) U; P = 0.26]. Likewise, no differences were found regarding the prevalence of on-ticagrelor high platelet reactivity between patients on ticagrelor 60 mg b.i.d vs. 90 mg b.i.d (VASP: 4% vs. 8%; P = 0.67; Multiplate: 15% vs. 8%; P = 0.54). Administration of reduced MD resulted in proportionally lower plasma concentrations of ticagrelor and its active metabolite on Day 45 after AMI. CONCLUSION: These results suggest that lowering ticagrelor MD 1 month after AMI confers an adequate antiplatelet effect that is comparable to the standard dose. The tested strategy warrants further research to assess its clinical efficacy and safety. CLINICALTRIALS.GOV IDENTIFIER: NCT03251859. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Jacek Kubica; Piotr Adamski; Piotr Niezgoda; Dimitrios Alexopoulos; Jolita Badarienė; Andrzej Budaj; Katarzyna Buszko; Dariusz Dudek; Tomasz Fabiszak; Mariusz Gąsior; Robert Gil; Diana A Gorog; Stefan Grajek; Paul A Gurbel; Marcin Gruchała; Miłosz J Jaguszewski; Stefan James; Young-Hoon Jeong; Bernd Jilma; Jarosław D Kasprzak; Andrzej Kleinrok; Aldona Kubica; Wiktor Kuliczkowski; Jacek Legutko; Maciej Lesiak; Jolanta M Siller-Matula; Klaudiusz Nadolny; Krzysztof Pstrągowski; Salvatore Di Somma; Giuseppe Specchia; Janina Stępińska; Udaya S Tantry; Agnieszka Tycińska; Monica Verdoia; Wojciech Wojakowski; Eliano P Navarese Journal: Cardiol J Date: 2020-10-19 Impact factor: 2.737
Authors: Jacek Kubica; Piotr Adamski; Piotr Niezgoda; Aldona Kubica; Przemysław Podhajski; Malwina Barańska; Julia M Umińska; Łukasz Pietrzykowski; Małgorzata Ostrowska; Jolanta M Siller-Matula; Jolita Badarienė; Stanisław Bartuś; Andrzej Budaj; Sławomir Dobrzycki; Łukasz Fidor; Mariusz Gąsior; Jacek Gessek; Marek Gierlotka; Robert Gil; Jarosław Gorący; Paweł Grzelakowski; Tomasz Hajdukiewicz; Miłosz Jaguszewski; Marianna Janion; Jarosław Kasprzak; Adam Kern; Artur Klecha; Andrzej Kleinrok; Wacław Kochman; Bartosz Krakowiak; Jacek Legutko; Maciej Lesiak; Marcin Nosal; Grzegorz Piotrowski; Andrzej Przybylski; Tomasz Roleder; Grzegorz Skonieczny; Grzegorz Sobieszek; Agnieszka Tycińska; Dariusz Wojciechowski; Wojciech Wojakowski; Jarosław Wójcik; Marzenna Zielińska; Aleksander Żurakowski; Giuseppe Specchia; Diana A Gorog; Eliano P Navarese Journal: Cardiol J Date: 2021-06-07 Impact factor: 2.737
Authors: Małgorzata Ostrowska; Jacek Kubica; Piotr Adamski; Aldona Kubica; Ceren Eyileten; Marek Postula; Aurel Toma; Christian Hengstenberg; Jolanta M Siller-Matula Journal: Front Cardiovasc Med Date: 2019-12-03
Authors: Piotr Adamski; Malwina Barańska; Małgorzata Ostrowska; Wiktor Kuliczkowski; Katarzyna Buszko; Katarzyna Kościelska-Kasprzak; Bożena Karolko; Andrzej Mysiak; Jacek Kubica Journal: J Clin Med Date: 2022-02-21 Impact factor: 4.241
Authors: Jacek Kubica; Piotr Adamski; Diana A Gorog; Aldona Kubica; Bernd Jilma; Andrzej Budaj; Jolanta M Siller-Matula; Paul A Gurbel; Dimitrios Alexopoulos; Jolita Badarienė; Paweł Dąbrowski; Dariusz Dudek; Evangelos Giannitsis; Grzegorz Horszczaruk; Miłosz J Jaguszewski; Stefan James; Young-Hoon Jeong; Michał Kryjak; Piotr Niezgoda; Małgorzata Ostrowska; Giuseppe Patti; Janusz Romanek; Salvatore Di Somma; Giuseppe Specchia; Udaya Tantry; Mariusz Gąsior; Agnieszka Tycińska; Wojciech Wojakowski; Katarzyna Buszko; Robert Gil; Marcin Gruchała; Jarosław Kasprzak; Andrzej Kleinrok; Jacek Legutko; Maciej Lesiak; Eliano P Navarese Journal: Cardiol J Date: 2021-10-08 Impact factor: 2.737