Atrial FibrillationNCT04121767
Safety and Efficacy of Edoxaban in Thoracoscopic Ablation
A study testing Edoxaban and Warfarin in people with Atrial Fibrillation and Anticoagulants and Bleeding Disorders, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Anticoagulants and Bleeding Disorders
- What is being tested?
- Edoxaban and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Dec 2017to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older (not exceed 80 years old).
- Elective thoracoscopic ablation.
- Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).
Who cannot join
- 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.
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- Malignancy.
- Intracardiac mass or thrombus
- Life expectancy less than 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation
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.
Read the 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
- Being tested
- Edoxaban, Warfarin
- Keywords
- atrial fibrillation, thoracoscopic ablation, anticoagulation
- Medical subject headings
- Atrial Fibrillation, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Also called Savaysa
oral edoxaban 60mg once daily for 3 months
WarfarinDrug
Also called Coumadin
oral warfarin once daily for 3 months according to prothrombin time
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban group | Experimental | patients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke Receives: Drug: Edoxaban |
| Warfarin group | Active comparator | patients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative stroke
Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation
Measured: 6 months
Secondary outcomes (2)
Postoperative bleeding
Number of patients showing bleeding events due to anticoagulation after thoracoscopic ablation
Measured: 6 months
Postoperative pericarditis
Number of patients showing pericarditis requiring readmission after thoracoscopic ablation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Dec 2017
- Primary completion30 Jun 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Seop Jeong, Samsung Medical Center
- Investigators
- Dong Seop Jeong, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121767
- Sponsor's protocol ID
- samsungmc_TTA_edoxaban
- Status last verified
- Jul 2020
- First submitted
- 8 Oct 2019
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Edoxaban Versus Warfarin in Patients Undergoing a Thoracoscopic Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04121767
- Acronym / sponsor ID
- samsungmc_TTA_edoxaban
- Keywords
- atrial fibrillation, thoracoscopic ablation, anticoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban group | Experimental | Drug: Edoxabanpatients prescribed edoxaban after thoracoscopic ablation during window period to prevent stroke |
| Warfarin group | Active comparator | Drug: Warfarinpatients prescribed warfarin after thoracoscopic ablation during window period to prevent stroke |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 years or older (not exceed 80 years old).
- Elective thoracoscopic ablation.
- Presence of atrial fibrillation (paroxysmal, persistent, long-standing persistent).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAlso: Savaysaoral edoxaban 60mg once daily for 3 months | Drug | Edoxaban group |
| WarfarinAlso: Coumadinoral warfarin once daily for 3 months according to prothrombin time | Drug | Warfarin group |
Primary outcome
Postoperative stroke
Time frame: 6 months
Number of patients showing thromboembolic neurologic complication after thoracoscopic ablation
2 secondary outcomes
Postoperative bleeding
Time frame: 6 months
Postoperative pericarditis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dong Seop Jeong, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edoxaban and Warfarin in people with Atrial Fibrillation and Anticoagulants and Bleeding Disorders, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative stroke (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.