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Withdrawn due to COVID19 pandemic. Several delays affected this study, therefore company decided to not conduct the study. It was cancelled prior to any enrollment.
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To determine if there is any difference in the effectiveness and safety outcomes of patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban and vitamin K antagonists
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Valvular Atrial Fibrillation (NVAF) Adults | Adult patients with NVAF newly treated with apixaban, dabigatran, rivaroxaban or VKAs between June 16, 2014 and December 31, 2018. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Adults receiving apixaban |
| |
| Measure | Description | Time Frame |
|---|---|---|
| stroke/systemic embolism event | To compare the risk of stroke (either ischemic or hemorrhagic) or SE among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | between 2014 and 2018 |
| major bleeding event | To compare the risk of major bleeding (gastrointestinal [GI], intracranial [IC] and other) among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versusVKAs. | between 2014 and 2018 |
| Measure | Description | Time Frame |
|---|---|---|
| ischemic stroke event | To compare the risk of ischemic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | between 2014 and 2018 |
| hemorrhagic stroke event |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients will be selected from the CCF database based on an apixaban, dabigatran, rivaroxaban or VKAs filled prescription between June 16, 2014 and December 31, 2018.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
| D000069604 | Dabigatran |
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
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Not applicable, this is a retrospective study
| dabigatran |
| Drug |
Adults receiving dabigatran |
|
| rivaroxaban | Drug | Adults receiving rivaroxaban |
|
| VKAs | Drug | Adults receiving VKA |
|
To compare the risk of hemorrhagic stroke among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs.
| between 2014 and 2018 |
| systemic embolism event | To compare the risk of systemic embolism among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | 2014-2018 |
| major GI bleeding event | To compare the risk of major GI bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | 2014-2018 |
| major IC bleeding event | To compare the risk of major IC bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | 2014-2018 |
| other major bleeding event | To compare the risk of other major bleeding among patients newly treated with each NOAC separately (apixaban, dabigatran, rivaroxaban) versus VKAs. | 2014-2018 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |