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NCT03188705 · ClinicalTrials.gov registry record · Phase 4
CES1 Carriers in the PAPI Study
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Completed
- Registry status
- Phase 4
- Development phase
- 6
- Enrollment target
NCT03188705: Completed Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT03188705 is a Phase 4 study that has completed, run by University of Maryland, Baltimore. The registered enrollment target is 6 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03188705, a Phase 4 study, has completed, sponsored by University of Maryland, Baltimore.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 6 participants
- Enrollment target
Study Summary
This study builds, in part, upon preliminary results generated as part of the Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1) on response to clopidogrel as well as dual antiplatelet therapy (i.e. clopidogrel and aspirin), as assessed by ex vivo platelet aggregometry, in healthy Amish individuals. The investigators hypothesize that participants who carry alleles that modify the activity or expression of CES1 will have altered response to clopidogrel as well as dual antiplatelet therapy.
Primary Outcome
Baseline minus post clopidogrel/pre-aspirin platelet rich plasma (PRP) maximum aggregation in response to ADP (20 ug/ml) or collagen (5 ug/ml). Maximum platelet aggregation is recorded by the platelet aggregometer as a percentage. Data shown below represent the maximum platelet aggregation value obtained at baseline (recorded as a percentage) minus the maximum platelet aggregation value obtained after clopidogrel administration but before aspirin administration (also recorded as percentage). Thu
Interventions
- DRUG Aspirin
- DRUG Clopidogrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-10-14 |
| Est. Completion | 2020-01-17 |
| Phase | Phase 4 |
What the finished NCT03188705 record still lists
NCT03188705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Aspirin is the first listed.
NCT03188705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03188705 about?
NCT03188705 is a clinical study titled "CES1 Carriers in the PAPI Study". This study builds, in part, upon preliminary results generated as part of the Pharmacogenomics Anti-Platelet Intervention (PAPI) Study (NCT00799396). The purpose of this investigation is to assess the impact of genetic variation in the carboxylesterase 1 (CES1) on response to clopidogrel as well as ...
What is the current status of trial NCT03188705?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 6 participants. The study started on 2019-10-14. Estimated completion is 2020-01-17.
What interventions are being tested in trial NCT03188705?
The interventions under investigation include: Aspirin (DRUG), Clopidogrel (DRUG).
Who is sponsoring clinical trial NCT03188705?
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 NCT03188705's enrollment target sits among peer trials
6 1983rd of 2000 higher than 12 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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