NCT04121767

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable atrial-fibrillation

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

August 3, 2020

Status Verified

July 1, 2020

Enrollment Period

2.6 years

First QC Date

October 8, 2019

Last Update Submit

July 31, 2020

Conditions

Atrial FibrillationAnticoagulants and Bleeding Disorders

Keywords

atrial fibrillationthoracoscopic ablationanticoagulation

Outcome Measures

Primary Outcomes (1)

  • Postoperative stroke

    Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation

    6 months

Secondary Outcomes (2)

  • Postoperative bleeding

    6 months

  • Postoperative pericarditis

    6 months

Study Arms (2)

Edoxaban group

EXPERIMENTAL

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

Drug: Edoxaban

Warfarin group

ACTIVE COMPARATOR

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

Drug: Warfarin

Interventions

EdoxabanDRUG

oral edoxaban 60mg once daily for 3 months

Also known as: Savaysa
Edoxaban group
WarfarinDRUG

oral warfarin once daily for 3 months according to prothrombin time

Also known as: Coumadin
Warfarin group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Atrial FibrillationHemostatic Disorders

Interventions

edoxabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dong Seop Jeong, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 10, 2019

Study Start

December 1, 2017

Primary Completion

June 30, 2020

Study Completion

July 10, 2020

Last Updated

August 3, 2020

Record last verified: 2020-07

Locations

KR(1)