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| Name | Class |
|---|---|
| Lexicon Pharmaceuticals | INDUSTRY |
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This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents | Experimental | Platelet responsiveness will be assessed in the blood from subjects administered sotagliflozin, aspirin, clopidogrel, or apixaban in randomized order given as a single drug administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin (SOTA) followed by 3 drugs in a random order | Drug | 400 mg/day SOTA Each drug will be given daily for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Platelet aggregation | Measured from blood samples | Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Platelet granule secretion | Measured from blood samples | Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days. |
| Total thrombus activation with T-TAS | Measured from blood samples |
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Inclusion Criteria:
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Prieur | Contact | 734-763-8824 | famanda@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Holinstat, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.
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| Aspirin followed by 3 drugs in a random order | Drug | 81 mg/day Aspirin Each drug will be given daily for 2 weeks. |
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| Clopidogrel followed by 3 drugs in a random order | Drug | 75 mg/day clopidogrel Each drug will be given daily for 2 weeks. |
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| Eliquis followed by 3 drugs in a random order | Drug | 5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks. |
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| Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days. |
| Thromboelastography (TEG) | Measured from blood samples | Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days. |
| Platelet integrin activation | Measured from blood samples | Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days. |
| ID | Term |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
| C522181 | apixaban |
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