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Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

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ClinicalTrials.gov Identifier: NCT04121767
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Dong Seop Jeong, Samsung Medical Center

Brief Summary:
The aim of this study is to compare the safety and efficacy of edoxaban and warfarin for prevention of stroke during a 6-month follow up after total thoracoscopic ablation.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Anticoagulants and Bleeding Disorders Drug: Edoxaban Drug: Warfarin Not Applicable

Detailed Description:
In Korea, 5% of patients older than 65 years and 10% of patients older than 80 have a history of atrial fibrillation (AF), which is often associated with sudden death and stroke. Medication and percutaneous radiofrequency catheter ablation are commonly used treatment modalities. Pharmacotherapy is primarily symptomatic treatment; moreover, the effect of conversion to a normal rhythm is minimal, and mainly aimed at stabilizing heart rate. Catheter ablation is associated with a high incidence of recurrence in chronic AF, and it is difficult to treat left atrial appendage, thereby preventing discontinuation of anticoagulation therapy post procedure. Thoracoscopic ablation is known to be a less invasive and more effective modality to treat patients with chronic atrial fibrillation. However, anticoagulation therapy is mandatory in the early postoperative period due to intracardiac thromboembolism associated with atrial stunning despite conversion to a sinus rhythm and resection of the left atrial appendage. Further investigation would be required to assess the efficacy and safety of novel oral anticoagulants such as edoxaban compared to that of warfarin for stroke prevention during the early postoperative period (6 months) after a thoracoscopic procedure. The need to maintain a constant level of blood coagulation and the potential development of complications such as hemorrhages are drawbacks associated with the use of warfarin. While novel oral anticoagulants such as edoxaban do have a role in atrial fibrillation, data regarding their effectiveness and incidence of complications after arrhythmia surgery do not exist. In this study, we will compare warfarin and edoxaban with respect to safety and efficacy, after they are used for 6 months following thoracoscopic ablation in patients with chronic atrial fibrillation

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Edoxaban group
patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke
Drug: Edoxaban
oral edoxaban 60mg once daily for 3 months
Other Name: Savaysa

Active Comparator: Warfarin group
patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke
Drug: Warfarin
oral warfarin once daily for 3 months according to prothrombin time
Other Name: Coumadin




Primary Outcome Measures :
  1. Postoperative stroke [ Time Frame: 6 months ]
    Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation


Secondary Outcome Measures :
  1. Postoperative bleeding [ Time Frame: 6 months ]
    Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation

  2. Postoperative pericarditis [ Time Frame: 6 months ]
    Number of patients showing pericarditis requiring readmission after thoracoscopic ablation



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 years or older (not exceed 80 years old).
  2. Elective thoracoscopic ablation.
  3. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease (COPD).
  2. History of pulmonary tuberculosis.
  3. Other cardiac comorbidities including valvular disease, coronary artery disease.
  4. Congenital heart anomalies except for atrial septal defect.
  5. Known, clinically important anemia or thrombocytopenia.
  6. Pregnancy or lactation.
  7. Malignancy.
  8. Intracardiac mass or thrombus
  9. Life expectancy less than 1 year.

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): NCT04121767


Contacts
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Contact: Dong Seop Jeong, PhD 82-2-10-8629-9446 opheart1@gmail.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Dong Seop Jeong, PhD    82-2-10-8629-9446    opheart1@gmail.com   
Principal Investigator: Dong Seop Jeong, PhD         
Sub-Investigator: Young Keun On, PhD         
Sub-Investigator: Seung Jung Park, PhD         
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Dong Seop Jeong, PhD Samsung Medical Center

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Responsible Party: Dong Seop Jeong, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04121767     History of Changes
Other Study ID Numbers: samsungmc_TTA_edoxaban
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019

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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 Dong Seop Jeong, Samsung Medical Center:
atrial fibrillation
thoracoscopic ablation
anticoagulation
Additional relevant MeSH terms:
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Atrial Fibrillation
Hemostatic Disorders
Blood Coagulation Disorders
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Hemorrhagic Disorders
Warfarin
Edoxaban
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action