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

Overview

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).

Full Title of Study: “A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 20, 2021

Interventions

  • Drug: Edoxaban
    • Taking edoxaban (Lixiana™, Daiichi-Sankyo Inc.) 60mg once daily. The dose of edoxaban will be reduced to 30mg once daily in patients with estimated creatinine clearance 15≤CrCL≤50mL/min by Cockcroft-Gault equation or weight is ≤60kg.
  • Drug: Single Antiplatelet Agents
    • Type of antiplatelet agent is dependant upon the investigator’s discretion, but aspirin 100mg once daily is recommended.

Arms, Groups and Cohorts

  • Experimental: Edoxaban alone
  • Active Comparator: Combination of edoxaban plus single antiplatelet

Clinical Trial Outcome Measures

Primary Measures

  • Rate of net Clinical Outcome
    • Time Frame: 1 year
    • composites of death, stroke, systemic embolic event, myocardial infarction, unplanned revascularization of a major coronary artery, major bleeding, and clinically relevant non-major bleeding event

Secondary Measures

  • Rate of all cause death
    • Time Frame: 1 year
  • Rate of cardiovascular death
    • Time Frame: 1 year
  • Rate of myocardial infarction
    • Time Frame: 1 year
  • Rate of ischemic stroke
    • Time Frame: 1 year
  • Rate of systemic embolism
    • Time Frame: 1 year
  • Rate of unplanned revascularization
    • Time Frame: 1 year
  • Rate of composite of hard outcomes
    • Time Frame: 1 year
    • all cause death, myocardial infarction, ischemic stroke, and systemic embolism
  • Rate of stent thrombosis
    • Time Frame: 1 year
  • Rate of composite of Major or clinically relevant non-major bleeding
    • Time Frame: 1 year
    • Major bleeding Fatal bleeding Bleeding in the critical site (Intracranial, retroperitoneal, intraocular, intraspinal, intra-articular, pericardial, intramuscular with compartment syndrome) Bleeding causing a fall in haemoglobin level of 2g/dL or leading to transfusion of two or more units of whole blood or red cells. Clinically relevant non-major bleeding Requires or prolongs hospitalization Requires lab evaluation Requires imaging studies Requires nasal packing or compression Requires a therapeutic procedure Requires interruption of study medication Requires a change in concomitant therapy
  • Rate of fatal bleeding
    • Time Frame: 1 year
    • International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
  • Rate of major bleeding
    • Time Frame: 1 year
    • ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
  • Rate of minor bleeding
    • Time Frame: 1 year
    • ISTH, BARC and TIMI criteria
  • Rate of intracranial hemorrhage
    • Time Frame: 1 year
  • Rate of gastrointestinal hemorrhage
    • Time Frame: 1 year

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gi-Byoung Nam
  • Collaborator
    • CardioVascular Research Foundation, Korea
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Gi-Byoung Nam, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea – Asan Medical Center
  • Overall Official(s)
    • Duk-woo Park, MD, Principal Investigator, Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
  • Overall Contact(s)
    • Jung-hee Ham, PL, 82230104728, cvcrc5@amc.seoul.kr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.