XASSURE: 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
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) 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. |
Drug: Rivaroxaban (Xarelto, BAY 59-7939)
Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
|
Outcome Measures
Primary Outcome Measures
- Number of Major bleeding events [Up to 30 months]
Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with: a fall in haemoglobin of ≥2 g/dL, or a transfusion of ≥2 units of packed red blood cells or whole blood, or occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or death
Secondary Outcome Measures
- Number of Symptomatic thromboembolic events [Up to 30 months]
Collected as serious or non-serious adverse events
- Number of Non-major bleeding [Up to 30 months]
Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings
- Treatment satisfaction questionnaire [Up to 30 months]
- Adverse event and serious adverse event percentage in the different atrial fibrillation risk factor categories [Up to 30 months]
- Number of each reason for any switch from or interruption of rivaroxaban treatment [Up to 30 months]
If the patients switch from or interruption of rivaroxaban treatment, patients or physicians will be asked by several questions about the reasons of the switch and interruption, and collected in CRF. The reasons will be described by frequency distributions. Reason choice as below: 1. Patient choice 2. Insufficient therapeutic effect 3. Adverse event 4. Surgery 5. Dentistry 6. Renal function change
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | HangZhou | China |
Sponsors and Collaborators
- Bayer
- Janssen Scientific Affairs, LLC
Investigators
- Study Director: Bayer Study Director, Bayer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 16819
- XA1207CN