Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects

George Washington University (GW)

Status: Withdrawn

Conditions: Thrombosis; Artery

Treatments: Drug: Ticagrelor Oral Tablet [Brilinta]

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04088123

Pharmacy Faculty Fund (Other Grant/Funding Number)

NCR191544

PIND 144269 (Other Identifier)

U54MD010723 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Healthy Patients

Description:

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.

Treatment:

Drug: Ticagrelor Oral Tablet [Brilinta]