Clinical trial NCT04088123: Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects
Official title: Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thrombosis; Artery
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Shenandoah University
name: The GW Medical Faculty Associates
First posted: 2019-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy patients who meet our inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of the Change in Platelet Activity From Baseline after Drug Administration
timeFrame: Comparison made 2.5 hours following drug administration
measure: Measurement of the Change in Platelet mRNA splicing From Baseline after Drug Administration
timeFrame: Comparison made 2.5 hours following drug administration
measure: Measurement of Ticagrelor Pharmacokinetics After Drug Administration
timeFrame: Comparison made 2.5 hours following drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University School of Medicine and Health Sciences
state: District of Columbia
city: Fairfax
country: United States
facility: Shenandoah University Bernard J. Dunn School of Pharmacy
state: Virginia
Study officials:
affiliation: George Washington University
name: Travis J O'Brien, PHD
role: PRINCIPAL_INVESTIGATOR
References: