Key result
The ELECTRA-SIRIO 2 trial is designed to evaluate whether reducing the ticagrelor maintenance dose to 60 mg twice daily, with or without aspirin continuation, reduces bleeding while maintaining anti-ischemic efficacy compared to standard therapy in patients with acute coronary syndrome.
Why the study?
Ischemic risk decreases after 1 month post-ACS while bleeding risk remains steady during DAPT, prompting evaluation of ticagrelor dose reduction with or without ASA withdrawal to improve tolerability, adherence, and safety while preserving efficacy.
Does ticagrelor dose reduction with or without continuation of ASA reduce clinically relevant bleeding in patients with acute coronary syndrome?
Does ticagrelor dose reduction with or without continuation of ASA reduce clinically relevant bleeding in patients with acute coronary syndrome?
The ELECTRA-SIRIO 2 trial is designed to evaluate whether de-escalating ticagrelor dose with or without aspirin withdrawal 1 month after ACS reduces bleeding without compromising ischemic protection.
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).
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Kubica et al. (2021) conducted a review in Acute coronary syndrome. Ticagrelor de-escalation (60 mg b.i.d. with or without ASA) vs. Ticagrelor 90 mg b.i.d. plus ASA was evaluated on First occurrence of BARC type 2, 3, or 5 bleeding (safety) and composite of death from any cause, nonfatal MI, or nonfatal stroke (efficacy). The ELECTRA-SIRIO 2 trial is designed to evaluate whether reducing the ticagrelor maintenance dose to 60 mg twice daily, with or without aspirin continuation, reduces bleeding while maintaining anti-ischemic efficacy compared to standard therapy in patients with acute coronary syndrome.
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