Thrombosis; Artery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Shenandoah University
The GW Medical Faculty Associates
George Washington University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Inclusion criteria
* 18 - 70 years-old * Speak and understand English
Exclusion criteria
* History of blood clotting/bleeding disorders * Current medications that are CYP3A4 inhibitors/inducers * Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per FDA recommendations. * Diagnosed with arterial or venous thrombosis * Active cancer diagnosis * Pregnant * Hepatic impairment including active hepatitis infection or cirrhosis * Current hormonal contraception * Currently taking aspirin or anti-platelet drugs. If patient has recently taken an NSAID, the last dose should have been discontinued based established criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of the Change in Platelet Activity From Baseline after Drug Administration | Comparison made 2.5 hours following drug administration | As determined by the VerifyNow P2Y12 Assay |
| Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration | Comparison made 2.5 hours following drug administration | As determined by RNAseq analysis |
| Measurement of Ticagrelor Pharmacokinetics After Drug Administration | Comparison made 2.5 hours following drug administration | Drug and its major metabolite levels will be measured by HPLC |
Countries
United States
Outcome results
None listed