Edoxaban alone and Edoxaban with antiplatelet agent in patients with atrial fibrillation and chronic stable coronary artery disease
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0003387
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1.Subject was = 19 years of age
2.Patients with nonvalvular AF with high embolic risk (CHA2DS2-VASc score =2,VASc=vascular disease (peripheral arterial disease, previous MI, aortic atheroma))
3.Patients with Stable Coronary artery disease
?coronary angiography (CAG) or Coronary computed tomography angiography (CCTA) confirmed Coronary artery disease (=50 % stenosis of major coronary artery) on medical treatment
?Revascularized Coronary artery disease (either percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)) whom the last revascularization should be performed =12 months before study enrollment for acute coronary syndrome and =6 months for stable angina pectoris.
1.Patients with thrombocytopenia (platelet count <100,000/ul)
2.High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)
3.Prior history of intracranial haemorrhage or haemorrhage on Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) imaging test
4.Mechanical prosthetic valve or moderate to severe mitral stenosis
5.The risk of bleeding increased due to the following reasons;
i. history of gastrointestinal ulcers within 1 month
ii. Malignant tumor with high risk of bleeding
iii. Brain or spinal cord injury within 1 month
iv. History of intracranial or intracerebral hemorrhage within 12 months
v. Esophageal varices
vi. Arteriovenous malformation
vii. Vascular aneurysms
viii. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
ix. Active bleeding
x. Hemoglobin level <7.0 g/dL or platelet count = 50,000 / mm3
xi. History of major surgery within 1 month
6. Patients who contraindicated for edoxaban
7. Uncontrolled severe hypertension
8. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy
9.History of hypersensitivity to Edoxaban or clopidogrel
10.Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
11.Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization
12.Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality)
13.Estimated CrCl by Cockcroft-Gault equation<15 mL/min
14.Life expectancy less than 12 months
15.The subject was unable to provide written informed consent or participate in long-term follow-up
16.Pregnant and/or lactating women
17.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of major coronary artery, major bleeding, and clinically relevant non-major bleeding event at 12 months
- Secondary Outcome Measures
Name Time Method All cause death;Cardiovascular death;Myocardial infarction;Ischemic stroke;Systemic embolism;Unplanned revascularization;Composite of hard outcomes (all cause death, myocardial infarction, ischemic stroke, and systemic embolism);Stent thrombosis;Composite of Major or clinically relevant non-major bleeding;Fatal bleeding;Major bleeding;Minor bleeding;Intracranial hemorrhage;Gastrointestinal hemorrhage