An observational study in Atrial Fibrillation and Renal Dysfunction, sponsored by Daiichi Sankyo. Completed at 2 sites in 2 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Daiichi Sankyo · Observational
This study aims to evaluate the recommended once-daily dosing of edoxaban and rivaroxaban in patients with atrial fibrillation (AF) and renal dysfunction in South Korea and Taiwan. The findings will contribute to the growing body of evidence needed to guide clinical practice in managing AF patients with renal impairment in Asian populations.
While pivotal trials such as ENGAGE AF-TIMI 48 and ROCKET AF have established the efficacy and safety of recommended doses of rivaroxaban and edoxaban, these studies have a limited inclusion of Asian patients with renal impairment. This reflects a need for further investigation in this specific population. Given the distinct clinical characteristics and prescribing practices in Asia, it is essential to evaluate the real-world clinical events of recommended dosing within this group.
The findings will contribute to a better understanding of optimal direct oral anticoagulants (DOAC) use in Asian populations, thereby improving stroke prevention strategies and minimizing bleeding complications in patients with NVAF and compromised renal function.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 8,265 is above the median of 300 across 1,390 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Daiichi Sankyo is the lead sponsor of 322 studies on the registry; 37 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 38 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population will consist of patients with non-valvular atrial fibrillation (NVAF) and moderate-to-severe renal dysfunction (CrCl 15 to 50 mL/min) who received treatment of edoxaban or rivaroxaban as per labelled use from selected hospitals in Korea and Taiwan.
Patients will be entered into this study only if they meet all of the following criteria:
Patients will be excluded from this study if they meet any of the following criteria:
1. Patients who had at least one inpatient or two outpatient records of diagnosis code for any following conditions during the 12-month baseline assessment period prior to the prescription of edoxaban or rivaroxaban:
Patients with NVAF and moderate-to-severe renal dysfunction (CrCl 15 to 50 mL/min) who received treatment of edoxaban between 01-Feb-2016 until one year prior to the date of data extraction as per labelled use from selected hospitals in Korea and Taiwan.
Drug: Edoxaban
Patients with NVAF and moderate-to-severe renal dysfunction (CrCl 15 to 50 mL/min) who received treatment of rivaroxaban between 01-Feb-2016 until one year prior to the date of data extraction as per labelled use from selected hospitals in Korea and Taiwan.
Drug: Rivaroxaban
Administered as per label
Administered as per label
Incidence of Composite Events (Major bleeding, All-cause mortality, Ischemic stroke or Systemic Embolism, Whichever Occurs First) During the Course of Study
Time frame: Retrospectively assessed from the first label-adherent prescription of edoxaban or rivaroxaban (index date) until the earliest of death, the end of treatment, or the country-specific data cutoff date, for up to approximately 8 years and 9 months.
Incidence of Individual Clinical Events and Composite Events
Individual clinical events (major bleeding, intracranial hemorrhage, major gastrointestinal bleeding, all-cause mortality, mortality due to cardiovascular events, ischemic stroke, and systemic embolism) and composite events (major bleeding, ischemic stroke or systemic embolism) will be assessed.
Time frame: Retrospectively assessed from the index date until the earliest of death, the end of treatment, or the country-specific data cutoff date, for up to approximately 8 years and 9 months.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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