A Real World Evidence Retrospective Data Collection Study of Edoxaban and Rivaroxaban

NCT07874555 | Completed

• 1 other identifier: DS-ASCAHQ-EDX-AF001
• Study Type: observational
• Target: 8,265
• Locations: 2 countries
• Sites: 2

Brief 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. 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.

Conditions

Atrial Fibrillation; Renal Dysfunction

Keywords

Atrial Fibrillation; Renal Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of Composite Events (Major bleeding, All-cause mortality, Ischemic stroke or Systemic Embolism, Whichever Occurs First) During the Course of Study

  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

  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.

Study Arms (2)

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.

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.

Drug: Rivaroxaban

Interventions

Edoxaban DRUG

Administered as per label

Edoxaban

Rivaroxaban DRUG

Administered as per label

Rivaroxaban

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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: 1. 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. 2. Confirmed diagnosis of non-valvular atrial fibrillation (NVAF) prior to or on the index date. 3. Most recently measured CrCl rate of 15 to 50 mL/min within 12 months prior to or on the index date. 4. 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. 5. 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: 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: 1. End Stage Renal Disease (CrCl \< 15 mL/min). 2. Venous thromboembolism (pulmonary embolism or deep vein thrombosis). 3. Valvular heart disease.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (2)

Severance Cardiovascular Hospital,

Seoul, 03722, South Korea

Location

Linkou Chang Gung Memorial Hospital

Taoyuan City, 333, Taiwan

Location

MeSH Terms

Conditions

Atrial Fibrillation; Renal Insufficiency

Interventions

edoxaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: December 25, 2025
• Primary Completion: September 25, 2026
• Study Completion: September 25, 2026
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); KR (1)