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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 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 111 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03161678
The ClinicalTrials.gov registry entry for NCT03161678 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 560 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT03161678 reports 0 study locations.
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.
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