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PI left the Institution; No replacement PI identified;
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The investigators are attempting to compare the anticoagulant (blood thinning) effects of a recently FDA approved medication, Rivaroxaban, in people who have undergone gastric bypass surgery to people who have not had this surgery. It is thought that gastric bypass may alter the absorption of this medication, but this has not been previously studied.
The investigators will study the anticoagulant effect of rivaroxaban in healthy volunteers who are in one of four groups
The study will involve taking a single low dose of rivaroxaban and multiple blood samples will be taken over the next 24 hours and the effect of rivaroxaban on blood clotting will be measured using the prothrombin time and an anti-factor Xa assay. The effects of rivaroxaban will be compared between the different groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| normal subjects | Experimental | A single dose of 10 mg of rivaroxaban will be administered |
|
| Obese non bypassed | Experimental | A single dose of rivaroxaban will be administered |
|
| obese bypassed | Experimental | A single dose of rivaroxaban will be administered |
|
| pre and post bypassed subject | Experimental | A single dose of rivaroxaban will be administered prior to gastric bypass. Subjects will be restudied 12 to 24 weeks following bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rivaroxaban | Drug | Single dose pharmacodynamic study |
|
| Measure | Description | Time Frame |
|---|---|---|
| median inhibition of factor xa inhibition | pharmacodynamic | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| median prolongation of prothrombin time | pharmacodynamic | 24 hours |
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Inclusion Criteria:
Healthy volunteers in one of four groups
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas E Coyle, MD | State University of New York - Upstate Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
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|
| D010078 |
| Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |