Last updated on June 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Stable Angina | Atrial Fibrillation | Stable Chronic Angina | Coronary Artery Disease | Coronary heart disease
  • Age: Between 19 - 100 Years
  • Gender: Male or Female

Inclusion Criteria

  1. A subject was 19 years of age
  2. Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score 2)
  3. Patients with Stable coronary artery disease
    • Coronary artery angiography or Coronary Computed Tomography Angiography confirmed coronary artery disease (50 % stenosis of a major coronary artery) on medical treatment
    • 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.

Exclusion Criteria

  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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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