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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose Group | Apixaban - 10 mg/day Rivaroxaban - 20 mg/day Dabigatran - 300 mg/day | ||
| Low Dose Group | Apixaban - 5 mg/day Rivaroxaban - 15 mg/day Dabigatran - 220 mg/day | ||
| Other Dose Group | Invalid Doses / Off-Label |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy | Approximately 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of patient demographics at the time of OAC initiation | at baseline | |
| Distribution of clinical characteristics at the time of OAC initiation | at baseline | |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion 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 | Ravenna | 48121 | Italy |
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| Composite of number and percentage of patients who are persistent with their newly prescribed OAC |
| Approximately 30 months |
| Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy | Approximately 30 months |
| Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC | Approximately 30 months |