Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects
NCT ID: NCT04088123
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2020-04-01
2020-09-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Ticagrelor Oral Tablet [Brilinta]
A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.
Interventions
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Ticagrelor Oral Tablet [Brilinta]
A single loading dose of ticagrelor (180 mg) will be administered to each participant in this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Speak and understand English
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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National Institute on Minority Health and Health Disparities (NIMHD)
NIH
Shenandoah University
OTHER
The GW Medical Faculty Associates
OTHER
George Washington University
OTHER
Responsible Party
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Travis J. O'Brien
Associate Professor of Pharmacology and Physiology
Principal Investigators
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Travis J O'Brien, PHD
Role: PRINCIPAL_INVESTIGATOR
George Washington University
Locations
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The George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, United States
Shenandoah University Bernard J. Dunn School of Pharmacy
Fairfax, Virginia, United States
Countries
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Other Identifiers
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Pharmacy Faculty Fund
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PIND 144269
Identifier Type: OTHER
Identifier Source: secondary_id
NCR191544
Identifier Type: -
Identifier Source: org_study_id