NCT04747496

Real-world Study on Edoxaban Treatment for Patients With Non-valvular Atrial Fibrillation in China

Real-world Study on Edoxaban Treatment in Routine Clinical Practice for Patients With Non-valvular Atrial Fibrillation in China

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The safety of edoxaban treatment will be examined using real-world clinical evidence from adult patients with non-valvular atrial fibrillation (NVAF) indications in routine clinical practice.

Detailed description

This non-interventional, observational study will evaluate the safety of edoxaban treatment in adult patients with NVAF indications with one or more risk factors. The primary objective of the study is to collect and evaluate safety data up to 2 years in a real-world setting in relation to adverse event onset (related to edoxaban treatment), duration, severity, and outcome. The secondary objective will evaluate the effect of edoxaban treatment on stroke (ischemic and hemorrhagic), systemic embolic event (SEE), transient ischemic attack (TIA), major adverse cardiovascular events (MACE), venous thromboembolism (VTE), acute coronary syndrome (ACS), hospitalization related to cardiovascular condition, extent of exposure and compliance to edoxaban therapy, and rate and reasons of permanent discontinuation of edoxaban therapy.

Conditions

• Non-valvular Atrial Fibrillation

Interventions

Type	Name	Description
DRUG	Edoxaban	This is a non-interventional, observational study.

Timeline

• Start date: 2021-02-26
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2021-02-10
• Last updated: 2025-01-09

Locations

97 sites across 1 country: China

Regulatory

• FDA-regulated drug study