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| ID | Type | Description | Link |
|---|---|---|---|
| DBOX 2014/00799 | Other Identifier | Company internal |
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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivaroxaban | Non-valvular Atrial Fibrillation (NVAF) patients who were initiated on rivaroxaban for stroke prevention |
| |
| Vitamin K antagonists (VKA) | NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | As prescribed by treating physicians |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI) | Composite cardiovascular endpoint | Within 1 year after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first occurrence of IS | Single cardiovascular event | Within 1 year after treatment start |
| Time to first occurrence of TIA | Single cardiovascular event |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with non-valvular atrial fibrillation (NVAF)
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Germany |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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| Vitamin K antagonists |
| Drug |
As prescribed by treating physicians |
|
| Within 1 year after treatment start |
| Time to first occurrence of IH | Single cardiovascular event | Within 1 year after treatment start |
| Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Single cardiovascular event | Within 1 year after treatment start |
| Time to first occurrence of MI | Single cardiovascular event | Within 1 year after treatment start |
| Incidence density in study population of IS | Within 1 year after treatment start |
| Incidence density in study population of TIA | Within 1 year after treatment start |
| Incidence density in study population of IH | Within 1 year after treatment start |
| Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage | Within 1 year after treatment start |
| Incidence density in study population of MI | Within 1 year after treatment start |
| Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI | Within 1 year after treatment start |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |