Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial): Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial

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  • Carl Johan Malm
  • Joakim Alfredsson
  • David Erlinge
  • Tomas Gudbjartsson
  • Jarmo Gunn
  • Stefan James
  • Møller, Christian H.
  • Susanne J. Nielsen
  • Ulrik Sartipy
  • Theis Tønnessen
  • Anders Jeppsson

The TACSI trial (ClinicalTrials.gov Identifier: NCT03560310) tests the hypothesis that 1-year treatment with dual antiplatelet therapy with acetylsalicylic acid (ASA) and ticagrelor is superior to only ASA after isolated coronary artery bypass grafting (CABG) in patients with acute coronary syndrome. The TACSI trial is an investor-initiated pragmatic, prospective, multinational, multicenter, open-label, registry-based randomized trial with 1:1 randomization to dual antiplatelet therapy with ASA and ticagrelor or ASA only, in patients undergoing first isolated CABG, with a planned enrollment of 2200 patients at Nordic cardiac surgery centers. The primary efficacy end point is a composite of time to all-cause death, myocardial infarction, stroke, or new coronary revascularization within 12 months after randomization. The primary safety end point is time to hospitalization due to major bleeding. Secondary efficacy end points include time to the individual components of the primary end point, cardiovascular death, and rehospitalization due to cardiovascular causes. High-quality health care registries are used to assess primary and secondary end points. The patients will be followed for 10 years. The TACSI trial will give important information useful for guiding the antiplatelet strategy in acute coronary syndrome patients treated with CABG.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind259
Sider (fra-til)1-8
Antal sider8
ISSN0002-8703
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The trial is funded by Swedish Research Council (grant 2017-00495 to AJ), The Swedish Heart Lung Foundation (grants 2017-0459 to AJ; 2018-0560 to AJ, 2021-0433 to AJ) the Swedish state under an agreement between the Swedish government and the county councils concerning economic support of research and education of doctors (ALF agreement) (grants ALFGBG 925251 to AJ; ALFGBG 725131 to AJ; ALFGBG 966204 to AJ. There is no industrial involvement or support.

Publisher Copyright:
© 2023 The Authors

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