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 :
Terminated
(Majority of enrolled patients have withdrawn.)
First Posted : March 8, 2017
Last Update Posted : September 9, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Drug: Antiplatelet Drug: Low dose oral anticoagulant Drug: Standard dose oral anticoagulant | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 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 |
Actual Primary Completion Date : | December 15, 2019 |
Actual Study Completion Date : | December 15, 2019 |

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 |
- 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

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

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
Korea, Republic of | |
Korea University Anam Hospital | |
Seoul, Korea, Republic of | |
Korea University Guro Hospital | |
Seoul, Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of | |
Yonsei University Severance Hospital | |
Seoul, Korea, Republic of |
Principal Investigator: | Hong Euy Lim, Dr. | Korea University Guro Hospital |
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: | September 9, 2020 |
Last Verified: | September 2020 |
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 |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Aspirin Edoxaban Anticoagulants Clopidogrel Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Factor Xa Inhibitors |