Safety and Efficacy of Edoxaban in Thoracoscopic Ablation

NCT ID: NCT04121767

Last Updated: 2020-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2020-07-10

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

Conditions

Atrial Fibrillation; Anticoagulants and Bleeding Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Edoxaban group

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

Group Type: EXPERIMENTAL

Edoxaban

Intervention Type: DRUG

oral edoxaban 60mg once daily for 3 months

Warfarin group

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

Group Type: ACTIVE_COMPARATOR

Warfarin

Intervention Type: DRUG

oral warfarin once daily for 3 months according to prothrombin time

Interventions

Edoxaban

oral edoxaban 60mg once daily for 3 months

Intervention Type: DRUG

Warfarin

oral warfarin once daily for 3 months according to prothrombin time

Intervention Type: DRUG

Other Intervention Names

Savaysa; Coumadin

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dong Seop Jeong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dong Seop Jeong, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

samsungmc_TTA_edoxaban

Identifier Type: -

Identifier Source: org_study_id