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| Name | Class |
|---|---|
| Daiichi Sankyo Korea Co., Ltd., a Daiichi Sankyo Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban treatment | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | Edoxaban will be used for resolution of left atrial appendage thrombi |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete resolution of LAA thrombi | The percentage of subjects with complete resolution of LAA thrombi | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment responses of thrombi | Treatment responses of thrombi: Number of participants with resolved, reduced, unchanged, enlarged thrombi or newly appeared thrombi | 6 weeks |
| Ischemic stroke event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seongwook Han, M.D., Ph.D. | Keimyung University Dongsan Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea | |||
| Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital |
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The percentage of subjects who experienced ischemic stroke
| 12 weeks |
| Bleeding event | The percentage of subjects who experienced bleeding event | 12 weeks |
| Daegu |
| 41944 |
| South Korea |
| Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital | Daegu | 42415 | South Korea |
| Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center | Daegu | 42472 | South Korea |
| Catholic University of Korea, Incheon St. Mary's hospital | Incheon | 21431 | South Korea |
| Pusan National University Hospital | Pusan | 49241 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Cardiovascular Hospital | Seoul | 03722 | South Korea |
| Seoul Samsung Medical Center | Seoul | 06351 | South Korea |
| Catholic University of Korea Yeouido St. Mary's Hospital | Seoul | 07345 | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | 26426 | South Korea |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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