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

NCT04088123 | Withdrawn FDA Drug

• 4 other identifiers: NCR191544U54MD010723Pharmacy Faculty FundPIND 144269
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Thrombosis; Artery

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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.

Drug: Ticagrelor Oral Tablet [Brilinta]

Interventions

Ticagrelor Oral Tablet [Brilinta] DRUG

A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.

Also known as: Brilinta

Healthy Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy patients who meet our inclusion and exclusion criteria

You may qualify if:

• years-old
• Speak and understand English

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Shenandoah University: collaborator
• The GW Medical Faculty Associates: collaborator

Study Sites (2)

The George Washington University School of Medicine and Health Sciences

Washington D.C., District of Columbia, 20037, United States

Location

Shenandoah University Bernard J. Dunn School of Pharmacy

Fairfax, Virginia, 22601, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

The following materials will be obtained from each participant. Blood for RNA (RNAseq) and DNA (genotyping) and platelet activity analysis.

MeSH Terms

Conditions

Thrombosis

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Travis J O'Brien, PHD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacology and Physiology

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: April 1, 2020
• Primary Completion: September 23, 2020
• Study Completion: September 23, 2020
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)