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

  • STATUS
    Recruiting
  • End date
    Jun 15, 2022
  • participants needed
    1028
  • sponsor
    Gi-Byoung Nam
Updated on 24 January 2021
angiography
computed tomography angiography
stenosis
aspirin
artery disease
atrial fibrillation
angina pectoris
percutaneous coronary intervention
coronary artery stenosis
stable angina
antiplatelet agents
bypass graft
fibrillation
acute coronary syndrome
coronary artery bypass graft
vascular disease
coronary artery bypass
bypass surgery
edoxaban
arterial disease
revascularisation

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).

Details
Condition Arrhythmia, Coronary Artery Disease, Coronary heart disease, Atrial Fibrillation, Angina Pectoris, Stable Angina, Stable Angina Pectoris, Atrial Fibrillation (Pediatric), Angina, Cardiac Ischemia, Dysrhythmia, Myocardial Ischemia, Stable Chronic Angina
Treatment Edoxaban, Single Antiplatelet Agents
Clinical Study IdentifierNCT03718559
SponsorGi-Byoung Nam
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 19 yrs?
Gender: Male or Female
Do you have any of these conditions: Arrhythmia or Coronary heart disease or Dysrhythmia or Atrial Fibrillation or Stable Angina or Angina or Angina Pectoris or Coronary Artery Disease or...?
Do you have any of these conditions: Stable Angina Pectoris or Stable Chronic Angina or Coronary Artery Disease or Arrhythmia or Atrial Fibrillation (Pediatric) or Atrial Fibrillation or ...?
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 (platelet count <100,000/ul)
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
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