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

• Status: Recruiting
• Trial end date: 2022-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gi-Byoung Nam
• Collaborator: CardioVascular Research Foundation, Korea
• Treatments: Edoxaban; Platelet Aggregation Inhibitors

Criteria

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. In case there is clinically significant moderate or more stenosis however the percentage of stenosis on CAG or CCTA is not shown, it will be at the investigator's discretion.

• 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

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. Uncontrolled severe hypertension

7. Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy

8. History of hypersensitivity to Edoxaban or clopidogrel

9. Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

10. Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization

11. Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality)

12. Estimated CrCl by Cockcroft-Gault equation<15 mL/min

13. Life expectancy less than 12 months

14. The subject was unable to provide written informed consent or participate in long-term follow-up

15. Pregnant and/or lactating women

16. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period