Background: Ticagrelor monotherapy after short-term dual-antiplatelet therapy (DAPT) may optimize ischemic and bleeding risks, particularly for acute coronary syndrome (ACS) patients, because its strategy is less potent than ticagrelor-based DAPT but more potent than aspirin or clopidogrel monotherapy. Methods: The TICO randomized open-label trial will evaluate whether ticagrelor monotherapy following 3-month DAPT is superior to 12-month ticagrelor-based DAPT in terms of net adverse clinical events (NACE) including efficacy and safety in ACS patients treated with ultrathin bioresorbable polymer sirolimus-eluting stents (BP-SES). Patients undergoing BP-SES implantation for ACS treatment will be randomized in a 1:1 fashion to the (1) ticagrelor monotherapy group after 3-month DAPT; or the (2) 12-month DAPT group. The primary endpoint is NACE within 12 months of percutaneous coronary intervention, which includes major adverse cardiac and cerebrovascular events (MACCE) plus major bleeding as defined by Thrombolysis in Myocardial Infarction. MACCE includes the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, and target vessel revascularization. Secondary endpoints included each component of the primary endpoint. Conclusions: The TICO trial is an ongoing trial evaluating the efficacy and safety of ticagrelor monotherapy following 3-month DAPT exclusively in ACS patients treated with uniform BP-SES. It may provide novel insights regarding the need for adjusted use of DAPT for rebalancing risk–benefit in current practice and changing from the conventional concept of aspirin maintenance to a ticagrelor-based regimen in the management of ACS.
Bibliographical noteFunding Information:
This study received support from the Investigator Sponsored Study Program of AstraZeneca (Cambridge, UK) and Biotronik (Bülach, Switzerland) as well as the Cardiovascular Research Center in Seoul, Korea. It was also supported by a grant from the Korea Healthcare Technology Research and Development Project, Ministry for Health and Welfare, Republic of Korea (nos. A085136 and HI15C1277) as well as by the Mid-Career Researcher Program through an NRF grant funded by the MEST, Republic of Korea (no. 2015R1A2A2A01002731).
This trial is investigator-initiated with grant support from AstraZeneca (Cambridge, UK) and Biotronik (Bülach, Switzerland). Other than financial sponsorship, the companies played no role in the study or decision to publish. The executive committee has a pivotal role with overall responsibility for the concept, design, and execution of the study progress in accordance with scientific, medical, ethical, and practical elements. The committee will convene a meeting to ensure the good execution and management of the study's progress, execution, and management and take charge of data management including its acquisition, security, analysis, and reporting. The study adheres to the ethical principles of the Declaration of Helsinki, and its protocol was approved by the institutional review board at each participating center.
© 2019 Elsevier Inc.
All Science Journal Classification (ASJC) codes
- Cardiology and Cardiovascular Medicine