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NCT00642174 · ClinicalTrials.gov registry record · Phase 2
Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)
A Phase 2 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT00642174: Completed Phase 2 study, sponsored by Eli Lilly and Company.
NCT00642174 is a Phase 2 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00642174, a Phase 2 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance therapy with high-dose clopidogrel loading dose and 1 week of high-dose clopidogrel maintenance therapy in patients with drug treated type 2 diabetes mellitus who have coronary artery disease. Various assays of platelet function will be used in this study. Platelet function will be studied using the following assays: Accumetrics VerifyNowTM P2Y12, Light Transmittance Aggregometry (LTA), Vasodilator-associated stimulated phosphoprotein (VASP), and Thromboelastography (TEG)-platelet mapping.
Primary Outcome
The inhibition of platelet aggregation 4 hours after the loading dose was administered was assessed using the Accumetrics VerifyNow™ P2Y12 assay. Percentage inhibition, as reported by VerifyNow™ P2Y12, was calculated from P2Y12 Reaction Unit (PRU) (rate and extent of adenosine diphosphate \[ADP\]-stimulated platelet aggregation) and BASE (estimate of baseline platelet reactivity independent of P2Y12 receptor inhibition \[reference values\]: rate and extent of Thrombin Receptor-Activated Peptide-
Interventions
- DRUG Clopidogrel
- DRUG prasugrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-04 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
What the finished NCT00642174 record still lists
NCT00642174 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT00642174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00642174 about?
NCT00642174 is a clinical study titled "Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)". This trial is designed as a phase 2 randomized, double-blind double dummy, active comparator controlled, two-period two-arm crossover study to enroll 40 patients across multiple centers. The study will compare platelet function following a prasugrel loading dose and 1 week of prasugrel maintenance t...
What is the current status of trial NCT00642174?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2008-04. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00642174?
The interventions under investigation include: Clopidogrel (DRUG), prasugrel (DRUG).
Who is sponsoring clinical trial NCT00642174?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00642174's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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