- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03840291
Resolution of Thrombi in Left Atrial Appendage With Edoxaban (REFLEX)
Non-valvular (NV) atrial fibrillation (AF) increases the risk of stroke by approximately fivefold. The atrial thrombi associated with AF are seen within the left atrial appendage (LAA) in most cases (> 90%). Anticoagulation with a vitamin-K antagonist (VKA) is recommended to prevent thromboembolic complications and to resolve thrombi. Non-VKA oral anticoagulants (NOACs) have replaced the VKA for the thromboprophylaxis in patients with NVAF since 2010. Therefore, NOAC can be the excellent alternative to VKA concerning resolving preexisting LAA thrombi because of its rapid onset of action and no need of bridging with heparin. However, there is still lack of data regarding the optimal treatment for patients with AF and thrombi in LAA with NOAC. There are only several case reports of the efficacy of NOACs in resolving LAA thrombi available.
Edoxaban, which has data showing efficacy and safety in thromboprophylaxis, can be the new option for treatment of patients with AF and LAA thrombi. The purpose of this study is to evaluate the efficacy of Edoxaban in resolving the LAA thrombi, which is related with nonvalvular AF.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jongmin Hwang, M.D., Ph.D.
- Phone Number: +82-53-250-7333
- Email: dsmcep@dsmc.or.kr
Study Locations
-
-
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Daegu, Korea, Republic of, 41931
- Recruiting
- Keimyung University Dongsan Medical Center
-
Contact:
- Jongmin Hwang, M.D.
- Phone Number: +82-53-250-7333
- Email: dsmcep@dsmc.or.kr
-
Principal Investigator:
- Seongwook Han, MD, PhD
-
Sub-Investigator:
- Hyoung-Seob Park, MD
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Sub-Investigator:
- Jongmin Hwang, MD, PhD
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Daegu, Korea, Republic of, 41944
- Recruiting
- Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital
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Contact:
- Myung Hwan Bae, MD, PhD
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Daegu, Korea, Republic of, 42415
- Recruiting
- Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital
-
Contact:
- Dong Gu Shin, MD, PhD
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Daegu, Korea, Republic of, 42472
- Recruiting
- Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center
-
Contact:
- Young Soo Lee, MD, PhD
-
Incheon, Korea, Republic of, 21431
- Recruiting
- Catholic University of Korea, Incheon St. Mary's hospital
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Contact:
- Yoori Kim, MD, PhD
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Pusan, Korea, Republic of, 49241
- Recruiting
- Pusan National University Hospital
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Contact:
- Jinhee Ahn, MD
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
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Contact:
- Eue-Keun Choi, MD, PhD
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Seoul, Korea, Republic of, 02841
- Recruiting
- Korea University Anam Hospital
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Contact:
- Jong-Il Choi, MD, PhD
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Seoul, Korea, Republic of, 03722
- Recruiting
- Severance Cardiovascular Hospital
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Contact:
- Hui-Nam Pak, MD, PhD
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Seoul, Korea, Republic of, 06351
- Recruiting
- Seoul Samsung Medical Center
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Contact:
- Young Keun On, MD, PhD
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Seoul, Korea, Republic of, 07345
- Recruiting
- Catholic University of Korea Yeouido St. Mary's Hospital
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Contact:
- Ju-Youn Kim, MD
-
Wŏnju, Korea, Republic of, 26426
- Recruiting
- Wonju Severance Christian Hospital
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Contact:
- Min-Soo Ahn, MD, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Men or women aged ≥ 20 years
- Hemodynamically stable nonvalvular AF or atrial flutter
- LAA thrombus documented by TEE up to 72 hours prior to start of study medication
- VKA or NOAC-naïve or untreated within 1 month prior to sign the informed consent
- VKA pretreated but under the therapeutic International Normalized ratio levels (<2.0; documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
- Women of childbearing potential and men must agree to use adequate contraception when sexually active
Exclusion Criteria:
- Transient Ischemic Attack within 3 days prior to study inclusion
- Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
- Acute myocardial infarction within the last 14 days prior to study inclusion
- Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus
- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Edoxaban treatment
|
Edoxaban will be used for resolution of left atrial appendage thrombi
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complete resolution of LAA thrombi
Time Frame: 6 weeks
|
The percentage of subjects with complete resolution of LAA thrombi
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment responses of thrombi
Time Frame: 6 weeks
|
Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi
|
6 weeks
|
Ischemic stroke event
Time Frame: 12 weeks
|
The percentage of subjects who experienced ischemic stroke
|
12 weeks
|
Bleeding event
Time Frame: 12 weeks
|
The percentage of subjects who experienced bleeding event
|
12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Seongwook Han, M.D., Ph.D., Keimyung University Dongsan Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Embolism and Thrombosis
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Thrombosis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Edoxaban
Other Study ID Numbers
- 2018-09-041
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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