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A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

ABSTRACT: 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).

SUBMITTER: Kubica J

PROVIDER: S-EPMC8277001 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

Kubica Jacek J Adamski Piotr P Niezgoda Piotr P Kubica Aldona A Podhajski Przemysław P Barańska Malwina M Umińska Julia M JM Pietrzykowski Łukasz Ł Ostrowska Małgorzata M Siller-Matula Jolanta M JM Badarienė Jolita J Bartuś Stanisław S Budaj Andrzej A Dobrzycki Sławomir S Fidor Łukasz Ł Gąsior Mariusz M Gessek Jacek J Gierlotka Marek M Gil Robert R Gorący Jarosław J Grzelakowski Paweł P Hajdukiewicz Tomasz T Jaguszewski Miłosz M Janion Marianna M Kasprzak Jarosław J Kern Adam A Klecha Artur A Kleinrok Andrzej A Kochman Wacław W Krakowiak Bartosz B Legutko Jacek J Lesiak Maciej M Nosal Marcin M Piotrowski Grzegorz G Przybylski Andrzej A Roleder Tomasz T Skonieczny Grzegorz G Sobieszek Grzegorz G Tycińska Agnieszka A Wojciechowski Dariusz D Wojakowski Wojciech W Wójcik Jarosław J Zielińska Marzenna M Żurakowski Aleksander A Specchia Giuseppe G Gorog Diana A DA Navarese Eliano P EP

Cardiology journal 20210607 4

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 ...[more]

PMID: 34096012

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Dataset Information

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

Publications

A new approach to ticagrelor-based de-escalation of antiplatelet therapy after acute coronary syndrome. A rationale for a randomized, double-blind, placebo-controlled, investigator-initiated, multicenter clinical study.

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