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

Thrombosis; Artery Clinical Trial

Official title:

Investigation of Anti-platelet Drug Single Dose Exposure on Platelet mRNA Splicing in Healthy Subjects

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04088123
• Other study ID #: NCR191544
• Secondary ID: U54MD010723Pharm
• Status: Withdrawn
• Start date: April 1, 2020
• Est. completion date: September 23, 2020

Study information

• Verified date: October 2021
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 23, 2020
• Est. primary completion date: September 23, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Thrombosis
• Thrombosis; Artery

Intervention

Drug:
• Ticagrelor Oral Tablet [Brilinta]
A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.

Locations

Country	Name	City	State
United States	Shenandoah University Bernard J. Dunn School of Pharmacy	Fairfax	Virginia
United States	The George Washington University School of Medicine and Health Sciences	Washington	District of Columbia

Sponsors (4)

Lead Sponsor	Collaborator
George Washington University	National Institute on Minority Health and Health Disparities (NIMHD), Shenandoah University, The GW Medical Faculty Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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