Status:
WITHDRAWN
Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects
Lead Sponsor:
George Washington University
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Shenandoah University
Conditions:
Thrombosis; Artery
Eligibility:
All Genders
18-70 years
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 val...
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 determi...
Eligibility Criteria
Inclusion
- 18 - 70 years-old
- Speak and understand English
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 23 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04088123
Start Date
April 1 2020
End Date
September 23 2020
Last Update
October 28 2021
Active Locations (2)
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1
The George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, United States, 20037
2
Shenandoah University Bernard J. Dunn School of Pharmacy
Fairfax, Virginia, United States, 22601