Atrial FibrillationNCT07874555
A Real World Evidence Retrospective Data Collection Study of Edoxaban and Rivaroxaban
An observational study of Atrial Fibrillation and Renal Dysfunction, run by Daiichi Sankyo at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Renal Dysfunction
- What is being tested?
- Edoxaban and Rivaroxaban
- How many people
- 8,265 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Dec 2025to 25 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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:
- Age ≥ 20 years at the index date. The index date is defined as the date of the first prescription of label-adherent edoxaban or rivaroxaban.
- Confirmed diagnosis of non-valvular atrial fibrillation (NVAF) prior to or on the index date.
- Most recently measured CrCl rate of 15 to 50 mL/min within 12 months prior to or on the index date.
- Received a prescription for label-adherent dosing (as defined in the protocol) of either: edoxaban (30 mg or 15 mg once daily), or rivaroxaban (15 mg or 10 mg once daily) on the index date.
- Patients with no prescription of any oral anticoagulants (including dabigatran, apixaban, rivaroxaban, edoxaban, and warfarin) for at least 30 days prior to the index date.
Patients will be excluded from this study if they meet any of the following criteria:
- 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:
- End Stage Renal Disease (CrCl < 15 mL/min).
- Venous thromboembolism (pulmonary embolism or deep vein thrombosis).
- Valvular heart disease.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Evaluation of Recommended Once-daily Dosing of Edoxaban and Rivaroxaban in Patients With Atrial Fibrillation and Renal Dysfunction, the ERENAL Study in South Korea and Taiwan
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Renal Dysfunction
- Being tested
- Edoxaban, Rivaroxaban
- Keywords
- Atrial Fibrillation, Renal Dysfunction
- Medical subject headings
- Atrial Fibrillation, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
Administered as per label
RivaroxabanDrug
Administered as per label
| Study group | Role | What they receive |
|---|---|---|
| Edoxaban | 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. Receives: Drug: Edoxaban | |
| Rivaroxaban | 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. Receives: Drug: Rivaroxaban |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Composite Events (Major bleeding, All-cause mortality, Ischemic stroke or Systemic Embolism, Whichever Occurs First) During the Course of Study
Measured: 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.
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start25 Dec 2025
- Primary completion25 Sep 2026
- Study completion25 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8,265 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874555
- Sponsor's protocol ID
- DS-ASCAHQ-EDX-AF001
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recommended Once-daily Dosing of Edoxaban and Rivaroxaban in Patients With Atrial Fibrillation and Renal Dysfunction, the ERENAL Study in South Korea and Taiwan
- ClinicalTrials.gov ID
- NCT07874555
- Acronym / sponsor ID
- DS-ASCAHQ-EDX-AF001
- Conditions
- Atrial Fibrillation, Renal Dysfunction
- Keywords
- Atrial Fibrillation, Renal Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,265 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- 25 Sep 2026 (actual)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | – | Drug: EdoxabanPatients 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. |
| Rivaroxaban | – | Drug: RivaroxabanPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanAdministered as per label | Drug | Edoxaban |
| RivaroxabanAdministered as per label | Drug | Rivaroxaban |
Primary outcome
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.
1 secondary outcome
Incidence of Individual Clinical Events and Composite Events
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Renal Dysfunction, run by Daiichi Sankyo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.