Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Daiichi Sankyo Korea Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Non-valvular atrial fibrillation (NVAF) increases the risk of stroke by three- to five-fold, especially in elderly patients, creating a huge burden on medical system as well as a negative impact on patients' lives. Direct oral anticoagulants (DOACs) are recommended for patients with NVAF to prevent strokes. Real world data reveal the underuse of anticoagulation in the elderly, especially due to physicians' concern of bleeding, often neglecting the thromboembolic risk. This study is designed to evaluate the safety and effectiveness of edoxaban in Korean elderly patients with atrial fibrillation.
The objective of this study will be to evaluate the safety and effectiveness of edoxaban in patients 80 years of age or older with NVAF. This observational, non-interventional study will prospectively follow Korean patients who have been prescribed edoxaban at the discretion of the physician up to 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Edoxaban | Participants who were prescribed edoxaban within 8 weeks of study enrollment at the discretion of the physician and were prospectively followed to assess the efficacy and safety of prescribed edoxaban. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban | Drug | This is observational, non-interventional study. No study drug will be administered during this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality | Baseline up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite Events (Stroke, Systemic Embolism, or Cardiovascular Mortality), (Stroke, Systemic Embolism, or All-Cause Mortality), (Stroke [Ischemic, Hemorrhagic] or Systemic Embolism), and (Stroke [Ischemic, Hemorrhagic]) | Baseline up to 12 months | |
| Percentage of Participants With Stroke (Ischemic, Hemorrhagic), Systemic Embolism, Cardiovascular Mortality, and All-Cause Mortality |
Not provided
Inclusion Criteria:
Exclusion Criteria:
No influence on prescribing behavior as participants will only be included in the study after the physicians have made the clinical decision to prescribe edoxaban.
Not provided
Not provided
Not provided
The study population will include participants who are prescribed with edoxaban at the discretion of the physician within 8 weeks prior to enrollment. Data documentation will occur every 6 (± 90 days) and 12 months (± 90 days) from the start of edoxaban treatment. Patient visits will be conducted according to regular clinical care and should not be influenced by the foreseen data documentation time points.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | 15355 | South Korea | |||
| Dong-A University Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline up to 12 months |
| Number of Hospitalizations Related to Cardiovascular Conditions | Baseline up to 12 months |
| Percentage of Participants With Transient Ischemic Attack, Venous Thromboembolism, and Major Cardiovascular Events | Baseline up to 12 months |
| Number of Participants With Composite of Stroke, Systemic Embolic Events, Major Bleeding, or All-Cause Mortality, Based on Independent Risk Factors | Baseline up to 12 months |
| Number of Participants With Bleeding Events (Major, Clinically Relevant Non-Major, Minor, and Composite) | Baseline up to 12 months |
| Percentage of Participants With Edoxaban Dose Change, Based on Reason for Dose Change | Baseline up to 12 months |
| Percentage of Participants Who Permanently Discontinued Edoxaban, Based on Reason for Discontinuation | Baseline up to 12 months |
| Busan |
| 49201 |
| South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Samsung Changwon Center | Changwon | 51353 | South Korea |
| Dankook University Hospital | Cheonan | 31116 | South Korea |
| Soonchunhyang University Hospital | Cheonan | 31151 | South Korea |
| Kangwon National University Hospital | Chuncheon | 24289 | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
| Catholic University of Korea Daejeon St. Mary's Hospital | Daejeon | 34943 | South Korea |
| Chungnam University Hospital | Daejeon | 35015 | South Korea |
| National Health Insurance Service Ilsan Hospital | Goyang | 10444 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Chonnam Natinal University Hospital | Gwangju | 61469 | South Korea |
| Wonkwang University Hospital | Iksan | 54538 | South Korea |
| Gachon University Gil Medical Center | Incheon | 21565 | South Korea |
| Gyeongsang National University Hospital | Jinju | 52727 | South Korea |
| Seoul National University Bundang Hospital | Seongnam | 13620 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Kangbuk Samsung Hospital | Seoul | 03181 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| KyungHee University Hospital at GangDong | Seoul | 05278 | South Korea |
| Korea Veterans Health Medical Center | Seoul | 05368 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Catholic University of Korea Seoul St. Mary's Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hosptial | Seoul | 06973 | South Korea |
| Ewha Womans University Seoul Hospital | Seoul | 07804 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Catholic University of Korea St. Vincent's Hospital | Suwon | 16247 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C552171 | edoxaban |
Not provided
Not provided
Not provided