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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to test a novel diagnostic immunoassay of platelet function and compare it to the current gold standard platelet function assay by testing the response to aspirin and clopidogrel in a group of healthy volunteers and severely obese individuals and comparing the accuracy of the two tests. The secondary goals will be to evaluate the pharmacodynamic parameters of the antiplatelet agents across the two testing modalities and refine the cutoffs used for the novel assay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Healthy | Experimental | Low Dose Aspirin - 81mg daily for 7 days |
|
| Group B: Healthy | Experimental | High Dose Aspirin - 325mg daily for 7 days |
|
| Group C: Healthy | Experimental | Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days |
|
| Group D: Obese | Experimental | Low Dose Aspirin - 81mg daily for 7 days |
|
| Group E: Obese | Experimental | Clopidogrel 300mg on Day 1 and 75mg daily for 6 subsequent days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison at day 5 of pDrp1 Assay relative to Light Transmission Aggregometry | Sensitivity of pDrp1 assay for platelet inhibition at day 5 | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
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| Clopidogrel | Drug | Arms C and E |
|
| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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