Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD)

Gi-Byoung Nam

Status and phase: Completed; Phase 4

Conditions: Stable Chronic Angina; Coronary Artery Disease; Atrial Fibrillation; Stable Angina

Treatments: Drug: Edoxaban Monotherapy; Drug: Edoxaban plus Single Antiplatelet Agent

Study type: Interventional

Funder types: Other

Identifiers

NCT03718559

AMCCVEP2018-01

Details and patient eligibility

About

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).

Enrollment: 1,040 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. A subject was ≥ 18 years of age

2. Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2)

3. 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.

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

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. 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

6. Uncontrolled severe hypertension

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

8. History of hypersensitivity to Edoxaban, aspirin, 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,040 participants in 2 patient groups

Edoxaban alone

Experimental group

Treatment:

Drug: Edoxaban Monotherapy

Combination of edoxaban plus single antiplatelet

Active Comparator group

Treatment:

Drug: Edoxaban plus Single Antiplatelet Agent