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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 - 06/04/23

Doi : 10.1016/j.ahj.2023.01.011 
Carl Johan Malm, MD, PhD a, b, Joakim Alfredsson, MD, PhD c, d, David Erlinge, MD, PhD e, Tomas Gudbjartsson, MD, PhD f, g, Jarmo Gunn, MD, PhD h, Stefan James, MD, PhD i, Christian H. Møller, MD, PhD j, k, Susanne J. Nielsen, RN, PhD a, b, Ulrik Sartipy, MD, PhD l, m, Theis Tønnessen, MD, PhD n, o, Anders Jeppsson, MD, PhD a, b,
a Department of Molecular and Clinical Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden 
b Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden 
c Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden 
d Department of Cardiology, Linköping University Hospital, Linköping, Sweden 
e Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden 
f Department of Cardiothoracic Surgery, Landspitali University Hospital, Reykjavik, Iceland 
g Faculty of Medicine, University of Iceland, Reykjavik, Iceland 
h Heart Center, Turku University Hospital and University of Turku, Turku, Finland 
i Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden 
j Department for Cardiothoracic Surgery, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark 
k Clinical Medicine, University of Copenhagen, Copenhagen, Denmark 
l Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden 
m Department of Cardiothoracic Surgery, Karolinska University Hospital, Stockholm, Sweden 
n Department of Cardiothoracic Surgery, Oslo University Hospital, Norway 
o University of Oslo, Oslo, Norway 

Reprint requests: Anders Jeppsson, Department of Cardiothoracic Surgery, Sahlgrenska University Hospital, Gothenburg, Sweden.Department of Cardiothoracic SurgerySahlgrenska University HospitalGothenburgSweden

Abstract

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 investigator-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.

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© 2023  The Authors. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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