Study to Gain Information on the Drug Xarelto for the Prevention of Brain Attack and Blockage of an Artery in the Non-central Nervous System Due to Irregular Heartbeat in Taiwanese Patients Suffering From Decreased Renal Function (XARETO)

Bayer

Status: Completed

Conditions: Non-valvular Atrial Fibrillation (NVAF)

Treatments: Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Observational

Funder types: Industry

Identifiers

NCT04356989

20901

Details and patient eligibility

About

In this study researchers want to learn more about on the safety of the drug Xarelto. The study will enroll patients for whom the treating doctor are prescribing Xarelto for the prevention of brain attack or the prevention of blockage of an artery in the non-central nervous system. Only patients suffering from decreased renal function and irregular heart beat will be considered. The study plans to include 500 Taiwanese adult male and female patients with the age above 20 years. Patients will be followed up based on routine medical practice over a period of 12 months and information on their well-being and any medical events will collected.

Enrollment: 493 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients ≥ 20 years of age
• Diagnosis of non-valvular atrial fibrillation (NVAF)
• Patients for whom the decision to initiate treatment with rivaroxaban is made as per physician's routine treatment practice
• Previously documented CrCl of 15-50 mL/min within 6 months before enrollment (last available value)

Exclusion criteria

• Contraindications for rivaroxaban according to the local market authorization/ Summary of Product Characteristics
• 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

493 participants in 1 patient group

Rivaroxaban

Description:

Adult NVAF patients with renal impairment, who are prescribed with rivaroxaban to prevent stroke or non-central nervous system (CNS) systemic embolism (SE).

Treatment:

Drug: Rivaroxaban (Xarelto, BAY59-7939)