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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-14

Study Completion Date

2023-11-08

Brief Summary

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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).

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Detailed Description

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Conditions

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Atrial Fibrillation Coronary Artery Disease Stable Angina Stable Chronic Angina

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Edoxaban alone

Group Type EXPERIMENTAL

Edoxaban Monotherapy

Intervention Type DRUG

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.

Combination of edoxaban plus single antiplatelet

Group Type ACTIVE_COMPARATOR

Edoxaban plus Single Antiplatelet Agent

Intervention Type DRUG

Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.

Interventions

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Edoxaban Monotherapy

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

Edoxaban plus Single Antiplatelet Agent

Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily or clopidogrel 75mg once daily was recommended.

Intervention Type DRUG

Other Intervention Names

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Lixiana™

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No