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NCT01097343 · ClinicalTrials.gov registry record · Phase 2
Clopidogrel Pharmacogenomics Project
A Phase 2 study of Disease Susceptibility, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01097343: Completed Phase 2 study of Disease Susceptibility, sponsored by University of North Carolina, Chapel Hill.
NCT01097343 is a Phase 2 study of Disease Susceptibility that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01097343, a Phase 2 study of Disease Susceptibility, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene, increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant reduction in the rate of measured clopidogrel resistance defined by multiple measures of platelet function
Primary Outcome
P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.
Conditions Studied
Interventions
- DRUG clopidogrel 75 mg
- DRUG Clopidogrel 150 mg
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT01097343 record still lists
NCT01097343 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with Disease Susceptibility appearing as the primary indexed condition, and to 2 interventions - of which clopidogrel 75 mg is the first listed.
NCT01097343 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01097343 about?
NCT01097343 is a clinical study titled "Clopidogrel Pharmacogenomics Project". Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene, increasing the maintenan...
What is the current status of trial NCT01097343?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2010-03. Estimated completion is 2011-05.
What conditions does trial NCT01097343 study?
This clinical trial studies the following conditions: Disease Susceptibility.
What interventions are being tested in trial NCT01097343?
The interventions under investigation include: clopidogrel 75 mg (DRUG), Clopidogrel 150 mg (DRUG).
Who is sponsoring clinical trial NCT01097343?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01097343 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01097343's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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