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

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ClinicalTrials.gov Identifier: NCT03718559
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
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 : 1000 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
Estimated Study Start Date : April 30, 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 below 50ml/min
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 below 50ml/min
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03718559


Contacts
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Contact: Jung-hee Ham, PL 82230104728 cvcrc5@amc.seoul.kr

Locations
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Korea, Republic of
Hallym University Medical Center Not yet recruiting
Anyang, Korea, Republic of
Contact: Kyung-ha Park, MD       pkhmd@naver.com   
Principal Investigator: Kyung-ha Park, MD         
Soon Chun Hyang University Hospital Bucheon Not yet recruiting
Bucheon, Korea, Republic of
Contact: Hyung-oh Choi, MD       mrgud@hanmail.net   
Principal Investigator: Hyung-oh Choi, MD         
Keimyung University Dongsan Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Jong-min Hwang, MD       hwangjongmin00@gmail.com   
Principal Investigator: Jong-min Hwang, MD         
Dong-A University Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Yong-rak Cho, MD       nephrone@dau.ac.kr   
Principal Investigator: Yong-rak Cho, MD         
Inje University Haeundae Paik Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Ki-hoon Kim, MD       iron9411@gmail.com   
Principal Investigator: Ki-hoon Kim, MD         
Seoul National University Bundang Hospital Not yet recruiting
Seongnam, Korea, Republic of
Contact: Ji-hyun Lee, MD       89family@hanmail.net   
Principal Investigator: Ji-hyun Lee, MD         
Asan Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Gi-byoung Nam, MD    +82230103159    gbnam@amc.seoul.kr   
Principal Investigator: Gi-byoung Nam, MD         
Kangbuk Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jong-young Lee, MD       jyleeheart@naver.com   
Principal Investigator: Jong-young Lee, MD         
Kangdong KyungHee University hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Eun-sun Jin, MD       eunsun.marcella@gmail.com   
Principal Investigator: Eun-sun Jin, MD         
Samsung Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Kyung-min Park, MD       kyoungmin.park@samsung.com   
Principal Investigator: Kyung-min Park, MD         
Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Eui-geun Choi, MD       choiek417@gmail.com   
Principal Investigator: Eui-geun Choi, MD         
The Catholic Univ. of Korea, Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Yong-suk Oh, MD       oys@catholic.ac.kr   
Principal Investigator: Yong-suk Oh, MD         
VHS medical center Not yet recruiting
Seoul, Korea, Republic of
Contact: Jin-kyung Hwang, MD       dangtong@naver.com   
Principal Investigator: Jin-kyung Hwang, MD         
Yonsei University Health System, Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Bo-young Jeong, MD       CBY6908@yuhs.ac   
Principal Investigator: Bo-young Jeong, MD         
The Catholic University of Korea, St. Vincent's Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: Yu-mi Hwang, MD       youmi0607@naver.com   
Principal Investigator: Ki-dong Yoo, MD         
Principal Investigator: Yu-mi Hwang, MD         
Ulsan Univeristy Hospital Not yet recruiting
Ulsan, Korea, Republic of
Contact: Kyung-min Park, MD       min8684@hanmail.net   
Principal Investigator: Kyung-min Park, MD         
Pusan National University Yangsan Hospital Not yet recruiting
Yangsan, Korea, Republic of
Contact: Ki-won Hwang, MD       korea.hwang@gmail.com   
Principal Investigator: Ki-won Hwang, MD         
Sponsors and Collaborators
Gi-Byoung Nam
CardioVascular Research Foundation, Korea
Investigators
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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
ClinicalTrials.gov Identifier: NCT03718559     History of Changes
Other Study ID Numbers: AMCCVEP2018-01
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
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:
Edoxaban
antiplatelet
anticoagulant

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Edoxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants