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.
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.
- 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.
- Observation: Case-Only
- Perspective: Prospective
- Sampling: Non-Probability Sample
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.
|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|