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A study involving real-world database analysis to evaluate the hospital healthcare utilization and costs, and all-cause, major bleeding-, clinically relevant bleeding-, any bleeding-, and venous thromboembolism (VTE)-related hospital readmissions among hospitalized VTE patients treated with apixaban or warfarin, with or without low molecular weight heparin (LMWH)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving apixaban | With or without low molecular weight heparin in the inpatient/emergency department (ED) setting | ||
| Patients receiving warfarin | With or without low molecular weight heparin in the inpatient/emergency department (ED) setting |
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| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of stay (LOS) | During the index hospitalization (Up to 30 days) | |
| Hospital cost | During the index hospitalization (Up to 30 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with major bleeding (MB)-related hospital readmissions | During 1 month after the index hospitalization | |
| Proportion of patients with clinically relevant bleeding (CRB)-related hospital readmissions | During 1 month after the index hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply
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The study population will include patients with a hospital or ED discharge International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or ICD-10 code indicating a primary diagnosis of VTE identified from the Premier Hospital database between 01-Aug-2014 and 31-May-2016. Patients who received apixaban or warfarin with or without LMWH during any time of the hospitalization (from admission to discharge) will be identified. Patients receiving both apixaban and warfarin, or any other direct oral anticoagulant (DOAC), including rivaroxaban, dabigatran, and edoxaban, during the index hospitalizations will be excluded from the study population. Patients will be required to have no evidence of atrial fibrillation (AF) or atrial flutter (AFL) during the index hospitalizations or the baseline periods.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Flemington | New Jersey | 08822 | United States |
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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 |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Proportion of patients with any bleeding-related hospital readmissions | During 1 month after the index hospitalization |
| Proportion of patients with VTE-related hospital readmissions | During 1 month after the index hospitalization |
| Proportion of patients with combined VTE- or MB-related hospital readmissions | During 1 month after the index hospitalization |
| Proportion of patients with all-cause hospital readmissions | During 1 month after the index hospitalization |
| Hospital Length of stay (LOS) for major bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for major bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for major bleeding-related hospital readmissions | During 1 month following the VTE hospitalization] |
| Mean number of hospital readmissions for major bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital LOS for clinically relevant bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for clinically relevant bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for clinically relevant bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Mean number of hospital readmissions for clinically relevant bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital LOS for any bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for any bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for any bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Mean number of hospital readmissions for any bleeding-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital LOS for VTE-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for VTE-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for VTE-related hospital readmissions | During 1 month following the VTE hospitalization |
| Mean number of hospital readmissions for VTE-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital LOS for combined VTE- or MB-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for combined VTE- or MB-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for combined VTE- or MB-related hospital readmissions | During 1 month following the VTE hospitalization |
| Mean number of hospital readmissions for combined VTE- or MB-related hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital LOS for all-cause hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital costs of readmissions for all-cause hospital readmissions | During 1 month following the VTE hospitalization |
| Hospital charges of readmissions for all-cause hospital readmissions | During 1 month following the VTE hospitalization |
| Mean number of hospital readmissions for all-cause hospital readmissions | During 1 month following the VTE hospitalization |