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"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed 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.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY 59-7939) Drug
    Intervention Desc: Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
    ARM 1: Kind: Experimental
    Label: 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.

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

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 within approved indication to prevent stroke or non-CNS systemic embolism has been made.

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of Major bleeding events Up to 30 months Yes
Secondary Number of Symptomatic thromboembolic events Up to 30 months Yes
Secondary Number of Non-major bleeding Up to 30 months Yes
Secondary Treatment satisfaction questionnaire Up to 30 months No
Secondary Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories Up to 30 months Yes
Secondary Number of each reason for any switch from or interruption of rivaroxaban treatment Up to 30 months No

Sponsors