Xarelto on Prevention of Stroke and Non-Central Nervous Systemic Embolism in Renally Impaired Korean Patients With Non-valvular Atrial Fibrillation (XARENAL)

Bayer

Status: Completed

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Treatments: Drug: Rivaroxaban(Xarelto,BAY 59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT03746301

20286

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and effectiveness of Xarelto in renally impaired patients with NVAF under routine practice conditions. The information collected in the XARENAL study will help to understand how renally impared patients with NVAF are treated in the real-world setting and what the outcome for the patients is under those conditions.

Enrollment: 924 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients ≥ 19 years of age
• Diagnosis of NVAF
• Patients for whom the decision to initiate treatment with rivaroxaban has already been made as per physician's routine treatment practice
• Previous documented creatinine clearance rate of 15-49mL/min within 6 months before enrollment
• Written informed consent of the patient

Exclusion criteria

• Contraindications for rivaroxaban according to the current Korean market authorization and Summary of Product Characteristics (SmPC).
• Patients participating in an investigational program with interventions outside of routine clinical practice.
• Planned treatment with other anticoagulants.
• Expected renal-replacement therapy within the next 3 months

Trial design

924 participants in 1 patient group

Treatment

Description:

Patients will be followed according to routine medical practice and the frequency of visits and procedures will be performed under routine conditions.

Treatment:

Drug: Rivaroxaban(Xarelto,BAY 59-7939)