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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is to compare the risk of major bleeding among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient initiating warfarin |
| ||
| Patient initiating apixaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major bleeding among oral anticoagulant (OAC) initiators | Maximum 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of thromboembolic events | Maximum 3 years | |
| Incidence of stoke/SE (secondary event) among OAC initiators | Maximum 3 years | |
| Incidence of major bleeding and stoke/SE (secondary event) among OAC initiators stratified by CCr |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Patients' medical charts with newly initiating warfarin or apixaban within the identification period fulfilling the study eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Minato-ku | Tokyo | 1080074 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37847442 | Derived | Morimoto T, Hoshino H, Matsuo Y, Ibuki T, Miyata K, Koretsune Y. Safety and Effectiveness of Apixaban Versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation Stratified by Renal Function: A Retrospective Cohort Study. Am J Cardiovasc Drugs. 2023 Nov;23(6):721-733. doi: 10.1007/s40256-023-00611-7. Epub 2023 Oct 17. |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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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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CCr creatinine clearance (< 50ml/min and > 50ml/min) |
| Maximum 3 years |
| Incidence of cardiovascular/all cause death among OAC initiators | Maximum 3 years |
| Incidence of myocardial infarction among OAC initiators | Maximum 3 years |
| Incidence of major adverse cardiac event among OAC initiators | Maximum 3 years |
| Incidence of cardiovascular/all cause death among OAC initiators stratified by CCr (creatinine clearance rate) | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years |
| Incidence of myocardial infarction among OAC initiators stratified by CCr | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years |
| Incidence of major adverse cardiac event among OAC initiators stratified by CCr | CCr (< 50ml/min and > 50ml/min) | Maximum 3 years |
| Distribution of clinical characteristics among OAC initiators | Clinical characteristics will be summarized using descriptive statistics | Maximum 3 years |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls | View source |
| D013568 |
| Pathological Conditions, Signs and Symptoms |