Evaluation of Treatment Safety in Patients With Atrial Fibrillation on Edoxaban Therapy in Real-Life in Turkey (ETAF-TR)

Daiichi Sankyo

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT04594915

ETAF-TR-01

Details and patient eligibility

About

This is a national, multi-center, prospective study to evaluate the safety of Edoxaban in patients diagnosed with AF who are currently using Edoxaban for stroke prevention.

The primary objective:

• To evaluate safety of Edoxaban treatment in patients with atrial fibrillation (AF) on Edoxaban therapy in routine clinical practice in Turkey.

Full description

Edoxaban was recently approved by The Turkish Medicines and Medical Devices Agency for the prevention of stroke and systemic embolism in adult patients with Nonvalvular Atrial Fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, diabetes mellitus, prior stroke or transient ischemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE in adults.

The study will evaluate the safety of Edoxaban in patients diagnosed with AF who are currently on Edoxaban therapy for prevention of stroke in routine clinical practice in Turkey for stroke prevention up to 1 year following treatment by specialized as well as non-specialized physicians in hospital centers.

Enrollment: 1,053 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Atrial fibrillation (AF) patients aged 18 years or above who are currently using Edoxaban for prevention of stroke.
• Has provided written informed consent to participate in the study.

Exclusion criteria

• Not on Edoxaban therapy on the date of obtaining Informed consent
• Receiving Edoxaban therapy for an indication other than the relevant indication (stroke prevention in AF)
• Participating in another ongoing clinical study will also be excluded.

Trial design

1,053 participants in 1 patient group

Study Group

Description:

Patients diagnosed with AF who are currently using Edoxaban for stroke prevention in Turkey.

Treatment:

Drug: Edoxaban