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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apixaban | Active Comparator | 30 participants prescribed Apixaban 3-14 days before and 28 days after CIED procedure. |
|
| Warfarin | Other | 30 participants will take stable dose of warfarin and go through the procedure without drug interrupt. The dose is adjusted by INR level. Length of treatment is 42 days, 14 days before and 28 days after the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug | Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change |
|
| Measure | Description | Time Frame |
|---|---|---|
| decrease in the hemoglobin level of 2 g per deciliter or more | Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin. | 2 months |
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Exclusion:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Mei Cha, MD | Mayo Clinic | Principal Investigator |
| Samuel Asirvatham, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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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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| ID | Term |
|---|---|
| C522181 | apixaban |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 |
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| Warfarin | Drug | Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change |
|
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |