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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03718559
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : August 18, 2021
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Gi-Byoung Nam, Asan Medical Center

Brief 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).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Coronary Artery Disease Stable Angina Stable Chronic Angina Drug: Edoxaban Drug: Single Antiplatelet Agents Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1038 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-centre, Open-labelled, Randomized Controlled Trial Comparing Two Different Anticoagulation Strategies in High-risk Atrial Fibrillation and Stable Coronary Artery Disease
Actual Study Start Date : May 14, 2019
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : June 15, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arm Intervention/treatment
Experimental: Edoxaban alone 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.
Other Name: Lixiana™

Active Comparator: Combination of edoxaban plus single antiplatelet 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.
Other Name: Lixiana™

Drug: Single Antiplatelet Agents
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily is recommended.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Rate of all cause death [ Time Frame: 1 year ]
  2. Rate of cardiovascular death [ Time Frame: 1 year ]
  3. Rate of myocardial infarction [ Time Frame: 1 year ]
  4. Rate of ischemic stroke [ Time Frame: 1 year ]
  5. Rate of systemic embolism [ Time Frame: 1 year ]
  6. Rate of unplanned revascularization [ Time Frame: 1 year ]
  7. Rate of composite of hard outcomes [ Time Frame: 1 year ]
    all cause death, myocardial infarction, ischemic stroke, and systemic embolism

  8. Rate of stent thrombosis [ Time Frame: 1 year ]
  9. Rate of composite of Major or clinically relevant non-major bleeding [ Time Frame: 1 year ]
    1. 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.
    2. 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

  10. Rate of fatal bleeding [ Time Frame: 1 year ]
    International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5

  11. Rate of major bleeding [ Time Frame: 1 year ]
    ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding

  12. Rate of minor bleeding [ Time Frame: 1 year ]
    ISTH, BARC and TIMI criteria

  13. Rate of intracranial hemorrhage [ Time Frame: 1 year ]
  14. Rate of gastrointestinal hemorrhage [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03718559

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Contact: Jung-hee Ham, PL 82230104728

Show Show 19 study locations
Sponsors and Collaborators
Gi-Byoung Nam
CardioVascular Research Foundation, Korea
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Principal Investigator: Duk-woo Park, MD Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
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Responsible Party: Gi-Byoung Nam, Professor, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea, Asan Medical Center Identifier: NCT03718559    
Other Study ID Numbers: AMCCVEP2018-01
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gi-Byoung Nam, Asan Medical Center:
Additional relevant MeSH terms:
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Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Platelet Aggregation Inhibitors
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action