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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD010723 | U.S. NIH Grant/Contract | View source | |
| Pharmacy Faculty Fund | Other Grant/Funding Number | Bernard J Dunn School of Pharmacy, Shenandoah University | |
| PIND 144269 | Other Identifier | US FDA IND Exemption |
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Inability to commence enrollment at institution, terminated on 9/23/20
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
| Shenandoah University | OTHER |
| The GW Medical Faculty Associates | OTHER |
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The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event.
There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in 10 healthy individuals.
It will test the hypothesis that ticagrelor exposure does not significantly alter platelet mRNA splicing. It will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Patients | The study design will involve analysis of platelet splicing/activity before and after exposure to a single, 180 mg loading dose of ticagrelor. All subjects will be cardiovascular healthy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor Oral Tablet [Brilinta] | Drug | A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the Change in Platelet Activity From Baseline after Drug Administration | As determined by the VerifyNow P2Y12 Assay | Comparison made 2.5 hours following drug administration |
| Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration | As determined by RNAseq analysis | Comparison made 2.5 hours following drug administration |
| Measurement of Ticagrelor Pharmacokinetics After Drug Administration | Drug and its major metabolite levels will be measured by HPLC | Comparison made 2.5 hours following drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy patients who meet our inclusion and exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Travis J O'Brien, PHD | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University School of Medicine and Health Sciences | Washington D.C. | District of Columbia | 20037 | United States | ||
No IPD will be shared with researchers. Only aggregate data from the study
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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The following materials will be obtained from each participant. Blood for RNA (RNAseq) and DNA (genotyping) and platelet activity analysis.
| Shenandoah University Bernard J. Dunn School of Pharmacy |
| Fairfax |
| Virginia |
| 22601 |
| United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |