This study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD \[≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD\]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,040
Taking edoxaban (Lixiana™, Daiichi-Sankyo Inc.) 60mg once daily. The dose of edoxaban will be reduced to 30mg once daily in patients with estimated creatinine clearance 15≤CrCL≤50mL/min by Cockcroft-Gault equation or weight is ≤60kg.
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.
Hallym University Medical Center
Anyang, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Dongguk University Ilsan Hospital
Ilsan, South Korea
Dong-A University Hospital
Pusan, South Korea
Inje University Haeundae Paik Hospital
Pusan, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Kangdong KyungHee University hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
...and 8 more locations
Rate of net Clinical Outcome
composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of a major coronary artery, major bleeding, and clinically relevant non-major bleeding event
Time frame: 1 year
Rate of all cause death
Time frame: 1 year
Rate of cardiovascular death
Time frame: 1 year
Rate of myocardial infarction
Time frame: 1 year
Rate of ischemic stroke
Time frame: 1 year
Rate of systemic embolism
Time frame: 1 year
Rate of unplanned revascularization
Time frame: 1 year
Rate of composite of hard outcomes
all cause death, myocardial infarction, ischemic stroke, and systemic embolism
Time frame: 1 year
Rate of stent thrombosis
Time frame: 1 year
Rate of composite of Major or clinically relevant non-major bleeding
1. Major bleeding * Fatal bleeding * Bleeding in the critical site (Intracranial, retroperitoneal, intraocular, intraspinal, intra-articular, pericardial, intramuscular with compartment syndrome) * Bleeding causing a fall in haemoglobin level of 2g/dL or leading to transfusion of two or more units of whole blood or red cells. 2. Clinically relevant non-major bleeding defined as any sign or symptom of haemorrhage that does not fit the criteria for The International Society on Thrombosis and Haemostasis (ISTH) major bleeding but requiring medical intervention, leading to hospitalization, or prompting a medical evaluation. Specifically bleeding that meet one of following criteria. * bleeding that resulted in hospitalization * medical or surgical intervention for bleeding * an unscheduled clinic visit, or * a change in physician-directed antithrombotic therapy.
Time frame: 1 year
Rate of fatal bleeding
International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
Time frame: 1 year
Rate of major bleeding
ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Time frame: 1 year
Rate of minor bleeding
ISTH, BARC and TIMI criteria
Time frame: 1 year
Rate of intracranial hemorrhage
Time frame: 1 year
Rate of gastrointestinal hemorrhage
Time frame: 1 year
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