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

Primary Purpose

Atrial Fibrillation, Coronary Artery Disease, Stable Angina

Status
Active
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Edoxaban
Single Antiplatelet Agents
Sponsored by
Gi-Byoung Nam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Edoxaban, antiplatelet, anticoagulant

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hallym University Medical Center
  • Soon Chun Hyang University Hospital Bucheon
  • Keimyung University Dongsan Medical Center
  • Dongguk University Ilsan Hospital
  • Dong-A University Hospital
  • Inje University Haeundae Paik Hospital
  • Seoul National University Bundang Hospital
  • Asan Medical Center
  • Kangdong KyungHee University hospital
  • Konkuk University Medical Center
  • Samsung Medical Center
  • Seoul National University Hospital
  • The Catholic Univ. of Korea, Seoul St. Mary's Hospital
  • The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital
  • VHS medical center
  • The Catholic University of Korea, St. Vincent's Hospital
  • Ulsan Univeristy Hospital
  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban alone

Combination of edoxaban plus single antiplatelet

Arm Description

Outcomes

Primary Outcome Measures

Rate of net Clinical Outcome
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

Rate of all cause death
Rate of cardiovascular death
Rate of myocardial infarction
Rate of ischemic stroke
Rate of systemic embolism
Rate of unplanned revascularization
Rate of composite of hard outcomes
all cause death, myocardial infarction, ischemic stroke, and systemic embolism
Rate of stent thrombosis
Rate of composite of Major or clinically relevant non-major bleeding
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
International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
Rate of major bleeding
ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Rate of minor bleeding
ISTH, BARC and TIMI criteria
Rate of intracranial hemorrhage
Rate of gastrointestinal hemorrhage

Full Information

First Posted
October 23, 2018
Last Updated
November 30, 2022
Sponsor
Gi-Byoung Nam
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT03718559
Brief Title
Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease
Acronym
EPIC-CAD
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2019 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gi-Byoung Nam
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Coronary Artery Disease, Stable Angina, Stable Chronic Angina
Keywords
Edoxaban, antiplatelet, anticoagulant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1050 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban alone
Arm Type
Experimental
Arm Title
Combination of edoxaban plus single antiplatelet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Lixiana™
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Single Antiplatelet Agents
Intervention Description
Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily is recommended.
Primary Outcome Measure Information:
Title
Rate of net Clinical Outcome
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of all cause death
Time Frame
1 year
Title
Rate of cardiovascular death
Time Frame
1 year
Title
Rate of myocardial infarction
Time Frame
1 year
Title
Rate of ischemic stroke
Time Frame
1 year
Title
Rate of systemic embolism
Time Frame
1 year
Title
Rate of unplanned revascularization
Time Frame
1 year
Title
Rate of composite of hard outcomes
Description
all cause death, myocardial infarction, ischemic stroke, and systemic embolism
Time Frame
1 year
Title
Rate of stent thrombosis
Time Frame
1 year
Title
Rate of composite of Major or clinically relevant non-major bleeding
Description
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
Time Frame
1 year
Title
Rate of fatal bleeding
Description
International Society on Thrombosis and Haemostasis(ISTH), The Bleeding Academic Research Consortium (BARC)5
Time Frame
1 year
Title
Rate of major bleeding
Description
ISTH, BARC 3, The Thrombolysis in Myocardial Infarction (TIMI) major bleeding
Time Frame
1 year
Title
Rate of minor bleeding
Description
ISTH, BARC and TIMI criteria
Time Frame
1 year
Title
Rate of intracranial hemorrhage
Time Frame
1 year
Title
Rate of gastrointestinal hemorrhage
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria A subject was ≥ 19 years of age Patients with nonvalvular atrial fibrillation with high embolic risk (CHA2DS2-VASc score ≥2) 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 Patients with thrombocytopenia High risk of bleeding which prohibits the anticoagulant use. (baseline comorbidities, hyper or hypercoagulable state, increased prothrombin time or activated partial thromboplastin time) Prior history of intracranial haemorrhage or haemorrhage on Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) imaging test Mechanical prosthetic valve or moderate to severe mitral stenosis 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 Uncontrolled severe hypertension Hemodynamically Unstable or pulmonary embolism requiring thrombolysis or pulmonary embolectomy History of hypersensitivity to Edoxaban or clopidogrel Genetic problem with galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Planned Percutaneous Coronary Intervention or coronary bypass surgery was planned within 1 year after randomization Liver cirrhosis or liver dysfunction (AST or ALT > x3 of normal range or coagulation abnormality) Estimated CrCl by Cockcroft-Gault equation<15 mL/min Life expectancy less than 12 months The subject was unable to provide written informed consent or participate in long-term follow-up Pregnant and/or lactating women Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duk-woo Park, MD
Organizational Affiliation
Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Medical Center
City
Anyang
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Dongguk University Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kangdong KyungHee University hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic Univ.of Korea Eunpyeong St.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
VHS medical center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon
Country
Korea, Republic of
Facility Name
Ulsan Univeristy Hospital
City
Ulsan
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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