Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT04121767

Collaborator

(none)

Enrollment

Location

Arms

31.3

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Anticoagulants and Bleeding Disorders	Drug: Edoxaban Drug: Warfarin	N/A

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

Study Design

Study Type:

Interventional

Actual 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 :

Dec 1, 2017

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Jul 10, 2020

Arms and Interventions

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 Names: 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 Names: Coumadin

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 Names:

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 Names:

Coumadin

Outcome Measures

Primary Outcome Measures

Postoperative stroke [6 months]
Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation

Secondary Outcome Measures

Postoperative bleeding [6 months]
Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation
Postoperative pericarditis [6 months]
Number of patients showing pericarditis requiring readmission after thoracoscopic ablation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.