TY - JOUR

T1 - Dual or single antiplatelet therapy after coronary surgery for acute coronary syndrome (TACSI trial)

T2 - Rationale and design of an investigator-initiated, prospective, multinational, registry-based randomized clinical trial

AU - Malm, Carl Johan

AU - Alfredsson, Joakim

AU - Erlinge, David

AU - Gudbjartsson, Tomas

AU - Gunn, Jarmo

AU - James, Stefan

AU - Møller, Christian H.

AU - Nielsen, Susanne J.

AU - Sartipy, Ulrik

AU - Tønnessen, Theis

AU - Jeppsson, Anders

N1 - Publisher Copyright: © 2023 The Authors

PY - 2023

Y1 - 2023

N2 - 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.

AB - 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.

U2 - 10.1016/j.ahj.2023.01.011

DO - 10.1016/j.ahj.2023.01.011

M3 - Journal article

C2 - 36681173

AN - SCOPUS:85147579647

VL - 259

SP - 1

EP - 8

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

ER -