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| ID | Type | Description | Link |
|---|---|---|---|
| XA1207CN | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Scientific Affairs, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY 59-7939) | Drug | Decision regarding dose and duration of treatment made at the discretion of the attending investigator. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Major bleeding events | Major bleeding events, collected as serious or non serious adverse events and defined as overt bleeding associated with:
| Up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Symptomatic thromboembolic events | Collected as serious or non-serious adverse events | Up to 30 months |
| Number of Non-major bleeding | Collected as serious or non-serious adverse events and defined as all bleeding events that do not fall in the category of major bleedings |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hangzhou | China |
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| Up to 30 months |
| 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 | 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 | Up to 30 months |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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