Xarelto on Prevention of Stroke and Non-central Nervous System Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in China: A Non-interventional Study (XASSURE)

Bayer

Status: Completed

Conditions: Stroke

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02784717

16819

XA1207CN (Other Identifier)

Details and patient eligibility

About

This non-interventional field study will investigate rivaroxaban under clinical practice conditions for stroke prevention and for prevention of non-CNS systemic embolism in patients with non-valvular atrial fibrillation in China.

Full description

3000 patients will be provided with free drug.It is planned to have an interim analysis(IA) when 3000 patients are enrolled (cut off day is the 3000th patient completed at least 3 months follow-up visit). To end or continue enrolling patients will be decided based on the IA result and the evaluation comments from CFDA.

Enrollment: 3,055 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female and male patients ≥ 18 years of age diagnosed with non-valvular atrial fibrillation
• Patients for whom the decision to initiate treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism was made as per investigator's routine treatment practice

Exclusion criteria

• NA

Trial design

3,055 participants in 1 patient group

Rivaroxaban (Xarelto, BAY 59-7939)

Description:

Female and male patients, who are at least 18 years of age with a diagnosis of non-valvular atrial fibrillation will be enrolled after the decision for a pharmacologic prophylaxis with rivaroxaban to prevent stroke or non-CNS systemic embolism has been made.

Treatment:

Drug: Rivaroxaban (Xarelto, BAY 59-7939)