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NCT03161678 · ClinicalTrials.gov registry record · Phase 4
CES1 Crossover Trial of Clopidogrel and Ticagrelor
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 111
- Enrollment target
NCT03161678: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT03161678 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 111 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161678, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. We hypothesize that genetic variation in CES1 will significantly impact on-clopidogrel platelet aggregation while having a minimal effect in ticagrelor-treated subjects. Specific Aim: To conduct a prospective randomized crossover study of clopidogrel and ticagrelor in healthy individuals stratified by CES1 genotype. Participants will be recruited by CES1 genotype into a randomized crossover study of clopidogrel (75 mg daily for 7d) and ticagrelor (90 mg twice daily for 7d) with extensive phenotyping including ex vivo platelet aggregometry performed pre- and post-drug administration in order to assess the interaction of genotype and drug choice on on-treatment platelet function.
Primary Outcome
Ex vivo platelet aggregometry was performed in platelet rich plasma (PRP) after stimulation with 20 μM adenosine diphosphate (ADP) at 2 time points (at baseline prior to drug administration and on the 8th day of clopidogrel \[75mg/d\]). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline minus the maximum platelet aggregation value obtained after clopidogrel administration. T
Interventions
- DRUG Clopidogrel
- DRUG Ticagrelor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-08-22 |
| Est. Completion | 2022-12-12 |
| Phase | Phase 4 |
What the finished NCT03161678 record still lists
NCT03161678 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT03161678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03161678 about?
NCT03161678 is a clinical study titled "CES1 Crossover Trial of Clopidogrel and Ticagrelor". The purpose of this investigation is to evaluate when genetic variation in the carboxylesterase 1 (CES1) gene influences antiplatelet therapy response, as assessed by ex vivo platelet aggregometry, in healthy participants treated with clopidogrel and ticagrelor. We hypothesize that genetic variation...
What is the current status of trial NCT03161678?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 111 participants. The study started on 2017-08-22. Estimated completion is 2022-12-12.
What interventions are being tested in trial NCT03161678?
The interventions under investigation include: Clopidogrel (DRUG), Ticagrelor (DRUG).
Who is sponsoring clinical trial NCT03161678?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03161678's enrollment target sits among peer trials
111 726th of 2000 higher than 1,274 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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