Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease

Korábbi kezelés

• Prior history of intracranial haemorrhage
• Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period

Más betegség

• High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time)
• Uncontrolled severe hypertension
• History of hypersensitivity to Edoxaban, aspirin, or clopidogrel

Laborértékek

• 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. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
  • vii. Active bleeding
  • viii. Hemoglobin level <7.0 g/dL or platelet count ≤ 50,000 / mm3
  • ix. History of major surgery within 1 month
• Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
• Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality)

Egyéb

• Patients with thrombocytopenia
• Mechanical prosthetic valve or moderate to severe mitral stenosis
• Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy
• Estimated CrCl by Cockcroft-Gault equation<15 mL/min
• Life expectancy less than 12 months
• The subject was unable to provide written informed consent or participate in long-term follow-up
• Pregnant and/or lactating women

• A subject was ≥ 18 years of age
• Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)
• Patients with Stable coronary artery disease
  • Anatomically confirmed coronary artery disease (with ≥50% stenosis of major epicardial coronary artery documented by cardiac catheterization or coronary computed tomographic angiography) on medical therapy alone.
  • Revascularized coronary artery disease (either Percutaneous Coronary Intervention or coronary bypass surgery) whom the last revascularization should be performed ≥12 months before study enrollment for the acute coronary syndrome and ≥6 months for stable angina pectoris.