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| Name | Class |
|---|---|
| Janssen Research & Development, LLC | INDUSTRY |
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The main objective of this project is to evaluate savings in direct costs as regards the use of rivaroxaban versus vitamin K antagonists (VKAs) in routine clinical practice using data from three cohorts of patients receiving VKAs or rivaroxaban in Spain, including the time in therapeutic range (TTR) values of the same and the incidence of events in the first year following diagnosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group with Rivaroxaban | Patients treated with Rivaroxaban |
| |
| Control group with VKAs | Patients treated with VKAs. This control group will be subsequently divided based on the TTR value in the last 6 months (below 65% and above 65%). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban (Xarelto, BAY59-7939) | Drug | As prescribed by treating physicians |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in therapeutic range (TTR) values in the last 6 months | 6 months | |
| Presence of stroke | Presence of stroke prior and subsequent to treatment | 12 months |
| Active substance received | Rivaroxaban or VKAs (Acenocoumarol and Warfarin) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Date of stroke | 12 months | |
| Type of stroke | Type of stroke acccording to patients group: unknown, haemorrhagic or ischaemic. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Date of AF diagnosis | 12 months | |
| Comorbidities | 12 months |
Inclusion Criteria:
Exclusion Criteria:
-
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Selected population will include records registered in electronic databases of patients diagnosed with nonvalvular AF, receiving treatment with VKAs or rivaroxaban for one year.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Granada | Spain |
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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 (VKAs) | Drug | As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin. |
|
| Duration of treatment (in days) |
| 12 months |
| Dose of the prescribed treatment | 12 months |
| Frequency of the prescribed treatment (in hours) | 12 months |
| 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 |