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| ID | Type | Description | Link |
|---|---|---|---|
| XA1206 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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This international study is a prospective noninterventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.
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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 descriptivestatistics 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:
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or noncentral nervous system systemic embolism.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Argentina | |||||
| 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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| after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Treatment satisfaction | 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 | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Reasons for switch of rivaroxaban treatment | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Reasons for interruption of rivaroxaban treatment | 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 therapy | after 1 year or until 30 days after end of rivaroxaban therapy, whichever is later |
| Many Locations |
| Azerbaijan |
| Many Locations | Bahrain |
| Many Locations | Chile |
| Many Locations | Colombia |
| Many Locations | Egypt |
| Many Locations | Georgia |
| ManyLocations | Jordan |
| Many Locations | Kazakhstan |
| Many Locations | Kenya |
| ManyLocations | Lebanon |
| Many Locations | Mexico |
| Many Locations | Russia |
| ManyLocations | Saudi Arabia |
| Many Locations | United Arab Emirates |
| Many Locations | Uruguay |
| Many Locations | Venezuela |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D004617 | Embolism |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| 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 |
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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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