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The purpose of this study is to compare the risk of major bleeding event among nonvalvular atrial fibrillation patients treated with warfarin, apixaban, dabigatran and rivaroxaban.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients using Warfarin | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Warfarin |
| |
| Patients using Apixaban | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Apixaban |
| |
| Patients using Dabigatran | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Dabigatran |
| |
| Patients using Rivaroxaban | Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using Rivaroxaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin | Drug |
| ||
| Apixaban |
| Measure | Description | Time Frame |
|---|---|---|
| Time to "First Major" Bleeding event | Up to 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to "First Any" Bleeding event | Up to 25 months | |
| Major Bleeding-Related Healthcare Utilization | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 major bleeding event ) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients 18 years of age and older with Non-Valvular Atrial Fibrillation (NVAF) using oral anticoagulants
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D014859 | Warfarin |
| C522181 | apixaban |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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|
| Dabigatran | Drug |
|
| Rivaroxaban | Drug |
|
| Up to 25 months |
| Any Bleeding-Related Healthcare Utilization | (Number of Hospitalizations, Total Length of Hospital Stay (days), Time to Hospitalization, Number Of Emergency Room (ER) visits, and Number of Outpatient Visits with at least 1 bleeding event ) | Up to 25 months |
| Major Bleeding-Related direct medical cost | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 major bleeding event) | Up to 25 months |
| Any Bleeding-Related direct medical cost | (Inpatient costs, Outpatient costs, and Emergency Room (ER) costs related to at least 1 bleeding event) | Up to 25 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011725 | Pyridines |
| D001562 | Benzimidazoles |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |