Jacek Gessek, Mariusz Gąsior, Dariusz Wojciechowski, Diana A. Gorog, Jolanta Maria Siller-Matula, Jolita Badarienė, Robert J. Gil, Piotr Niezgoda, Agnieszka Tycińska, Małgorzata Ostrowska, Grzegorz Piotrowski, Jacek Legutko, Giuseppe Specchia, Julia M. Umińska, Wojciech Wojakowski, Łukasz Pietrzykowski, Jarosław D. Kasprzak, Bartosz Krakowiak, Andrzej Budaj, Marcin Nosal, Piotr Adamski, Miłosz Jaguszewski, Jarosław Gorący, Jarosław Wójcik, Marianna Janion, Maciej Lesiak, Sławomir Dobrzycki, Grzegorz Sobieszek, Andrzej Przybylski, Wacław Kochman, Marek Gierlotka, Łukasz Fidor, Aldona Kubica, Paweł Grzelakowski, Andrzej Kleinrok, Artur Klecha, Aleksander Żurakowski, Przemysław Podhajski, Adam Kern, Jacek Kubica, Tomasz Roleder, Marzenna Zielińska, Malwina Barańska, Stanisław Bartuś, Grzegorz Skonieczny, Tomasz Hajdukiewicz, and Eliano Pio Navarese
The risk of ischemic events gradually decreases after acute coronary syndrome (ACS), reaching a stable level after 1 month, while the risk of bleeding remains steady during the whole period of dual antiplatelet treatment (DAPT). Several de-escalation strategies of antiplatelet treatment aiming to enhance safety of DAPT without depriving it of its efficacy have been evaluated so far. We hypothesized that reduction of the ticagrelor maintenance dose 1 month after ACS and its continuation until 12 months after ACS may improve adherence to antiplatelet treatment due to better tolerability compared with the standard dose of ticagrelor. Moreover, improved safety of treatment and preserved anti-ischemic benefit may also be expected with additional acetylsalicylic acid (ASA) withdrawal. To evaluate these hypotheses, we designed the Evaluating Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome - a randomized clinical trial (ELECTRA-SIRIO 2), to assess the influence of ticagrelor dose reduction with or without continuation of ASA versus DAPT with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients. The study was designed as a phase III, randomized, multicenter, double-blind, investigator-initiated clinical study with a 12-month follow-up (ClinicalTrials.gov Identifier: NCT04718025; EudraCT number: 2020-005130-15).