E5TION will evaluate the efficacy, safety and tolerability of tailored two regimens (prasugrel 5mg/d vs. ticagrelor 60mg bid) in high-risk patients undergoing PCI (CHIP: COmplex and Higher-Risk Indicated PCI/PatieNts).
Because CHIP (COmplex and Higher-Risk Indicated PCI/PatieNts) has been related with the increased risk of ischemic events following PCI, there are unmet needs to develop the tailored strategies (e.g., intensified antiplatelet treatment) for this cohort. During antithrombotic treatment, East Asian patients have been prone to bleed compared with Western patients ("East Asian Paradox"). For example, standard-dose potent P2Y12 inhibitors (e.g., ticagrelor, prasugrel) vs. clopidogrel did not demonstrate the better net clinical benefit in patients with acute coronary syndrome. One of the tailored antiplatelet strategies for East Asian patients would be the de-escalated strategy of potent P2Y12 inhibitors (e.g., ticagrelor, prasugrel). The ISAR-REACT5 trial showed the lower ischemic event and better tolerability of ticagrelor vs. prasugrel in ACS patients. This E5TION trial will compare the efficacy, safety and tolerability of the de-escalated strategies (low-dose prasugrel and ticagrelor) in East Asian patients with CHIP character.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
492
Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months
Gyeongsang National University Changwon Hospital
Changwon, Gyeongsangnam-do, South Korea
RECRUITINGGyeongsang National University Hospita
Jinju, Gyeongsangnam-do, South Korea
RECRUITINGPusan National University Yangsan Hospital
Major bleeding and adherence to DAPT regimen
Incidence of major bleeding (BARC type 2, 3 or 5) and prevalence of discontinuation/switch of antiplatelet regimen
Time frame: 1 year after PCI
MACE
Incidence of MACE (CV death, myocardial infarction, stent thrombosis, stroke or urgent revascularization)
Time frame: 1 year after PCI
Major bleeding
Incidence of BARC type 2, 3 or 5 bleeding
Time frame: 1 year after PCI
Major bleeding
Incidence of ISTH major bleeding or clinically relevant non-major (CRNM) bleeding
Time frame: 1 year post-PCI
Adherence to DAPT regimen
Prevalence of discontinuation/switch of antiplatelet regimen d/t side effect
Time frame: 1 year after PCI
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Yangsan, Gyeongsangnam-do, South Korea
Kosin University Gospel Hospital
Busan, South Korea
NOT_YET_RECRUITINGDong-A University Hospital
Busan, South Korea
NOT_YET_RECRUITINGPusan National University Hospital,
Busan, South Korea
NOT_YET_RECRUITINGInje University Busan Paik Hospital,
Busan, South Korea
NOT_YET_RECRUITINGUlsan University Hospital
Ulsan, South Korea
NOT_YET_RECRUITING