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Completed NCT07874555

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

Conditions: Atrial Fibrillation, Renal Dysfunction

Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Enrollment: 8265
Sponsor: Daiichi Sankyo

Location: Severance Cardiovascular Hospital, Seoul

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07874555). StuddyBuddy aggregates publicly available trial information.