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The primary objectives of this study are to compare the risk of major bleeding and stroke/systemic embolism (SE) events among oral anticoagulant (OAC)-naïve non-valvular atrial fibrillation (NVAF) patients initiating OAC warfarin or apixaban or dabigatran or rivaroxaban treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVAF patients on Warfarin | NVAF patients newly initiated with Warfarin. Non-Interventional. | ||
| NVAF patients on Apixaban | NVAF patients newly initiated on Apixaban. Non-Interventional. | ||
| NVAF patients on Dabigatran | NVAF patients newly initiated with Dabigatran. Non-Interventional. | ||
| NVAF patients on Rivaroxaban | NVAF patients newly initiated with Rivaroxaban. Non-Interventional. |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to first major bleeding event | Up to 33 months | |
| Time to first stroke/systemic embolism (SE) event | Up to 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major bleeding-related medical costs | Up to 33 months | |
| Stroke/SE-related medical costs | Up to 33 months | |
| All-cause Healthcare costs |
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Inclusion Criteria:
Exclusion Criteria:
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NVAF patients who were initiators of warfarin or apixaban or dabigatran or rivaroxaban treatment from 01-Jan-2013 through 30-Sep-2015. All patients who have at least 1 year of baseline data available and no prior OAC use will be included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32370854 | Derived | Lip GYH, Keshishian AV, Kang AL, Li X, Dhamane AD, Luo X, Balachander N, Rosenblatt L, Mardekian J, Nadkarni A, Pan X, Di Fusco M, Garcia Reeves AB, Yuce H, Deitelzweig SB. Effectiveness and Safety of Oral Anticoagulants in Patients With Nonvalvular Atrial Fibrillation and Diabetes Mellitus. Mayo Clin Proc. 2020 May;95(5):929-943. doi: 10.1016/j.mayocp.2019.05.032. | |
| 30571400 |
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
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| Up to 33 months |
| Lip GYH, Keshishian A, Li X, Hamilton M, Masseria C, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Baser O, Deitelzweig S. Effectiveness and Safety of Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients. Stroke. 2018 Dec;49(12):2933-2944. doi: 10.1161/STROKEAHA.118.020232. |
| 29373602 | Derived | Li X, Keshishian A, Hamilton M, Horblyuk R, Gupta K, Luo X, Mardekian J, Friend K, Nadkarni A, Pan X, Lip GYH, Deitelzweig S. Apixaban 5 and 2.5 mg twice-daily versus warfarin for stroke prevention in nonvalvular atrial fibrillation patients: Comparative effectiveness and safety evaluated using a propensity-score-matched approach. PLoS One. 2018 Jan 26;13(1):e0191722. doi: 10.1371/journal.pone.0191722. eCollection 2018. |
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