The purpose of ZEST-LATE (Evaluation of the Long-term Safety After Zotarolimus-Eluting Stent, Sirolimus-Eluting Stent, or PacliTaxel-Eluting Stent Implantation for Coronary Lesions - Late Coronary Arterial Thrombotic Events) trial is to assess the relationship between long-term clopidogrel use beyond 1 year and long-term rates of death or MI after DES implantation and to estimate the duration of dual antiplatelet therapy for preventing the late thrombotic events.
Prospective, two arms, open-labeled, randomized multi-center trial of approximately 2,000 patients enrolled at 19 centers in Korea. Among all patients enrolled in the ZEST (Comparison of the Efficacy of Zotarolimus-Eluting Stent versus Sirolimus-Eluting Stent versus PacliTaxel-Eluting Stent for Coronary Lesions) trial, event-free patients who survived the first 12 months without nonfatal MI or repeat revascularization will be randomized to discontinue clopidogrel therapy at 12 months after DES implantation. All patients will be followed for another 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,175
stopping clopidogrel at 1 year after DES implantation
continue aspirin and clopidogrel 1year after DES
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Composite of death or myocardial infarction
Time frame: at 12 months after randomization (at 24 months after ZEST enrollment)
All Death
Time frame: at 12 months after randomization
Cardiac death
Time frame: at 12 months after randomization
Myocardial infarction
Time frame: at 12 months after randomization
Stroke
Time frame: at 12 months after randomization
Target vessel revascularization (all and ischemia-driven)
Time frame: at 12 months after randomization
Target lesion revascularization (all and ischemia-driven)
Time frame: at 12 months after randomization
Stent thrombosis for the patients
Time frame: at 12 months after randomization
Bleeding event
Time frame: at 12 months after randomization
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Kyungpook National University Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Asan Medical Center
Gangneung, South Korea
Chonnam National University Hospital
Gwangju, South Korea
NHIC Ilsan Hospital
Ilsan, South Korea
Chonbuk National University Hospital
Jeonju, South Korea
Pusan Natioanal University Hospital
Pusan, South Korea
Hallym University Sacred Heart Hospital,
Pyeongchon, South Korea
...and 10 more locations