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Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Primary Purpose

Atrial Fibrillation, Anticoagulants and Bleeding Disorders

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Edoxaban
Warfarin
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring atrial fibrillation, thoracoscopic ablation, anticoagulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban group

Warfarin group

Arm Description

patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke

patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke

Outcomes

Primary Outcome Measures

Postoperative stroke
Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation

Secondary Outcome Measures

Postoperative bleeding
Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation
Postoperative pericarditis
Number of patients showing pericarditis requiring readmission after thoracoscopic ablation

Full Information

First Posted
October 8, 2019
Last Updated
July 31, 2020
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04121767
Brief Title
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
Official Title
Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
July 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Anticoagulants and Bleeding Disorders
Keywords
atrial fibrillation, thoracoscopic ablation, anticoagulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban group
Arm Type
Experimental
Arm Description
patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke
Arm Title
Warfarin group
Arm Type
Active Comparator
Arm Description
patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Savaysa
Intervention Description
oral edoxaban 60mg once daily for 3 months
Intervention Type
Drug
Intervention Name(s)
Warfarin
Other Intervention Name(s)
Coumadin
Intervention Description
oral warfarin once daily for 3 months according to prothrombin time
Primary Outcome Measure Information:
Title
Postoperative stroke
Description
Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Postoperative bleeding
Description
Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation
Time Frame
6 months
Title
Postoperative pericarditis
Description
Number of patients showing pericarditis requiring readmission after thoracoscopic ablation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 18 years or older (not exceed 80 years old). Elective thoracoscopic ablation. Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent). Exclusion Criteria: Chronic obstructive pulmonary disease (COPD). History of pulmonary tuberculosis. Other cardiac comorbidities including valvular disease, coronary artery disease. Congenital heart anomalies except for atrial septal defect. Known, clinically important anemia or thrombocytopenia. Pregnancy or lactation. Malignancy. Intracardiac mass or thrombus Life expectancy less than 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Seop Jeong, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

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