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Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (ATEMS-AF)

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ClinicalTrials.gov Identifier: NCT03073850
Recruitment Status : Recruiting
First Posted : March 8, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hong Euy Lim, MD, Korea University Guro Hospital

Study Description
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Brief 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). The investigators are going to compare antiplatelet therapy to oral anticoagulation (OAC) with different doses of edoxaban (30mg and 60mg).

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: Antiplatelet Drug: Low dose oral anticoagulant Drug: Standard dose oral anticoagulant Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Antithrombotic Treatment in Patients With Effectively Maintained Sinus Rhythm After Atrial Fibrillation Ablation (The ATEMS-AF Study)
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Edoxaban

Arms and Interventions
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Arm Intervention/treatment
Experimental: Antiplatelet therapy
acetylsalicylic acid (ASA) 100mg or clopidogrel 75mg if intolerant to ASA
 Drug: Antiplatelet
ASA or clopidogrel
Other Name: aspirin 100mg or clopidogrel 75mg
Experimental: Low-dose OAC therapy
Edoxaban of 30mg (Reduced dose of 15mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
 Drug: Low dose oral anticoagulant
Edoxaban of 30mg
Other Name: Edoxaban of 30mg
Active Comparator: Standard-dose OAC therapy
Edoxaban of 60mg (Reduced dose of 30mg if body weight < 60kg, CCr< 50 ml/min, concomittant use of P-gp)
 Drug: Standard dose oral anticoagulant
Edoxaban of 60mg
Other Name: Edoxaban of 60mg


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073850


Contacts
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Contact: Hong Euy Lim, Dr. 82-2-2626-1046 hongeuy1046@gmail.com
Contact: Do Young Kim, Dr. 82-2-2626-1046 sneeze_kr@naver.com

Locations
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Korea, Republic of
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jaemin Shim, Dr.         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hong Euy Lim, Dr.         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eue-Keun Choi, Dr.         
Yonsei University Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hui-Nam Pak, Dr.         
Sponsors and Collaborators
Korea University Guro Hospital
Investigators
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Principal Investigator: Hong Euy Lim, Dr. Korea University Guro Hospital
More Information
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Responsible Party: Hong Euy Lim, MD, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT03073850    
Other Study ID Numbers: KUGH12078-001
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Edoxaban
Clopidogrel
Anticoagulants
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
 Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors