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| ID | Type | Description | Link |
|---|---|---|---|
| XA1205 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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This is an international observational study in patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjudicated major bleeding events | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | |
| Safety variables will be summarized using descriptive statistics based on adverse events collection | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | |
| All cause mortality | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Measure | Description | Time Frame |
|---|---|---|
| Adjudicated symptomatic thromboembolic events | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later | |
| Non-major bleeding, collected as SAEs or non-serious AEs and defined as all bleeding events that do not fall in the category of major bleedings |
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Inclusion Criteria:
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Patients with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Hong Kong | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38941511 | Derived | Kirchhof P, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ. Causes of death in patients with atrial fibrillation anticoagulated with rivaroxaban: a pooled analysis of XANTUS. Europace. 2024 Jul 2;26(7):euae183. doi: 10.1093/europace/euae183. | |
| 29976287 | Derived | Kirchhof P, Radaideh G, Kim YH, Lanas F, Haas S, Amarenco P, Turpie AGG, Bach M, Lambelet M, Hess S, Camm AJ; Global XANTUS program Investigators. Global Prospective Safety Analysis of Rivaroxaban. J Am Coll Cardiol. 2018 Jul 10;72(2):141-153. doi: 10.1016/j.jacc.2018.04.058. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D004617 | Embolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Treatment satisfaction as per patient assessment of rivaroxaban treatment by the physician at the final visit | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Healthcare resource | Number of healthcare professional visits and hospitalizations due to anticoagulation | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Adverse events rates in the different AF risk factor categories | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Persistence with rivaroxaban treatment measured as percentage of patients on rivaroxaban treatment at 1 year after start of study treatment | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Reasons for switch of rivaroxaban treatment as per physician assessment during or at end of study | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Reasons for interruption of rivaroxaban treatment as per physician assessment during or at end of study | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Many Locations |
| India |
| Many Locations | Indonesia |
| Many Locations | Malaysia |
| Many Locations | Pakistan |
| Many Locations | Philippines |
| Many Locations | Singapore |
| Many Locations | South Korea |
| Many Locations | Taiwan |
| Many Locations | Thailand |
| Many Locations | Vietnam |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |