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A study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with apixaban | |||
| Participants treated with warfarin |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major bleeding in participants treated with apixaban | 2 years | |
| Incidence of major bleeding in participants treated with warfarin | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically relevant non-major bleeding event in participants treated with apixaban | 2 years | |
| Incidence of clinically relevant non-major bleeding event in participants treated with warfarin | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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The study population will comprise all persons aged ≥18 years who received outpatient treatment with apixaban or warfarin within 30 days following their first observed encounter for VTE, and who met all other qualifying 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 | Princeton | New Jersey | 08540 | 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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| Incidence of recurrent VTE in participants treated with apixaban | 2 years |
| Incidence of recurrent VTE in participants treated with warfarin | 2 years |