Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

Atrial Fibrillation Clinical Trial

Official title:

Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121767
• Other study ID #: samsungmc_TTA_edoxaban
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: July 10, 2020

Study information

• Verified date: July 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 10, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Atrial Fibrillation
• Blood Coagulation Disorders
• Hemostatic Disorders

Intervention

Drug:
• Edoxaban
oral edoxaban 60mg once daily for 3 months
• Warfarin
oral warfarin once daily for 3 months according to prothrombin time

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative stroke	Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation	6 months
Secondary	Postoperative bleeding	Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation	6 months
Secondary	Postoperative pericarditis	Number of patients showing pericarditis requiring readmission after thoracoscopic ablation	6 months