Atrial FibrillationPhase 4ATEMS-AFNCT03073850
Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation
A Phase 4 study testing Antiplatelet, Low dose oral anticoagulant and Standard dose oral anticoagulant in people with Atrial Fibrillation, run by Korea University Guro Hospital at 4 sites in South Korea.
Trial summary
The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Antiplatelet, Low dose oral anticoagulant and Standard dose oral anticoagulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 23 Feb 2017to 15 Dec 2019
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
- Willing and able to provide informed consent
Who cannot join
- Patients who do not meet all of the above listed inclusion criteria.
- Patients with significant valvular heart disease or mechanical valve.
- Patients with hypertrophic cardiomyopathy.
- Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.
- Patients with contraindication to long-term OAC.
- Patients who had a stroke within one year prior to enrolment.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Seoul National University Hospital
Seoul
Yonsei University Severance Hospital
Seoul
About this study
Official title: Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
The purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).
Read the detailed description
The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- Antiplatelet, Low dose oral anticoagulant, Standard dose oral anticoagulant
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiplateletDrug
Also called aspirin 100mg or clopidogrel 75mg
ASA or clopidogrel
Low dose oral anticoagulantDrug
Also called Edoxaban of 30mg
Edoxaban of 30mg
Standard dose oral anticoagulantDrug
Also called Edoxaban of 60mg
Edoxaban of 60mg
| Study group | Role | What they receive |
|---|---|---|
| Antiplatelet therapy | Experimental | acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA Receives: Drug: Antiplatelet |
| Low-dose OAC therapy | Experimental | Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp) Receives: Drug: Low dose oral anticoagulant |
| Standard-dose OAC therapy | Active comparator | Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp) Receives: Drug: Standard dose oral anticoagulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure
Check stroke or systemic embolism through neurologic examination or imaging studies
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start23 Feb 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Why it stopped: Majority of enrolled patients have withdrawn.
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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Euy Lim, MD, Korea University Guro Hospital
- Investigators
- Hong Euy Lim, Dr., Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073850
- Sponsor's protocol ID
- KUGH12078-001
- Acronym
- ATEMS-AF
- Status last verified
- Sep 2020
- First submitted
- 2 Feb 2017
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
- ClinicalTrials.gov ID
- NCT03073850
- Acronym / sponsor ID
- ATEMS-AF / KUGH12078-001
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Majority of enrolled patients have withdrawn.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 8 Mar 2017 (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 purpose of the study is to investigate the best strategy for long-term stroke prevention in patients who have sinus rhythm after a successful catheter ablation for atrial fibrillation (AF) and who are at risk of thromboembolic events (CHA2DS2-VASc score ≥2). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).
Detailed description
The investigators hypothesize that the strategy of OAC will be superior to antiplatelet therapy, but low dose edoxaban (30mg) will be non-inferior to standard dose edoxaban (60mg) for reducing the risk of stroke or systemic embolism in patients who underwent successful AF ablation. Although AF ablation is an effective therapy for reducing and/or eliminating the burden of AF, there may continue to be a risk of late recurrence or asymptomatic recurrence of atrial tachyarrhythmias. Until now, the guideline has recommended the continuation of OAC in patients who are at risk of stroke or systemic embolism based on the CHA2DS2-VASc score, even though they have maintained sinus rhythm. The annual rate of stroke, however, is still lower compared to that predicted by the scoring system, because AF ablation reduced the AF burden by 86% and the remaining episodes were significantly shorter in duration (median 6 minutes) than those pre-ablation reported by the previous study. Based on recent studies which demonstrated that both standard-dose and low-dose non-vitamin K OACs (NOAC) performed equally well with regard to the stroke prevention in patients with AF, low dose NOACs may also be sufficient for stroke prevention of briefly lasting AF episodes after successful AF ablation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Antiplatelet therapy | Experimental | Drug: Antiplateletacetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA |
| Low-dose OAC therapy | Experimental | Drug: Low dose oral anticoagulantEdoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp) |
| Standard-dose OAC therapy | Active comparator | Drug: Standard dose oral anticoagulantEdoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients without evidence of any clinically apparent arrhythmia recurrence during at least six months after last catheter ablation of AF.
- Willing and able to provide informed consent
Key exclusion criteria (6 listed)
- Patients who do not meet all of the above listed inclusion criteria.
- Patients with significant valvular heart disease or mechanical valve.
- Patients with hypertrophic cardiomyopathy.
- Patients with chronic renal impairment with creatinine clearance rate of < 30 mg/dl.
- Patients with contraindication to long-term OAC.
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 |
|---|---|---|
| AntiplateletAlso: aspirin 100mg or clopidogrel 75mgASA or clopidogrel | Drug | Antiplatelet therapy |
| Low dose oral anticoagulantAlso: Edoxaban of 30mgEdoxaban of 30mg | Drug | Low-dose OAC therapy |
| Standard dose oral anticoagulantAlso: Edoxaban of 60mgEdoxaban of 60mg | Drug | Standard-dose OAC therapy |
Primary outcome
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure
Time frame: 2 year
Check stroke or systemic embolism through neurologic examination or imaging studies
Results and safety
The study was stopped early (reason given: Majority of enrolled patients have withdrawn.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Atrial Fibrillation (AF)
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.
Hong Euy Lim, Dr. principal investigator
Korea University Guro Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antiplatelet, Low dose oral anticoagulant and Standard dose oral anticoagulant in people with Atrial Fibrillation, run by Korea University Guro Hospital at 4 sites 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 2 inclusion and 6 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Majority of enrolled patients have withdrawn.). Results are not available in the source record.
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?
Freedom rate of stroke or systemic embolism during 2 years after successful AF ablation procedure (time frame: 2 year). 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 9 Sep 2020.