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NCT01014624 · ClinicalTrials.gov registry record · Phase 4
Prasugrel/Clopidogrel Maintenance Dose Washout Study
A Phase 4 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 56
- Enrollment target
NCT01014624: Completed Phase 4 study, sponsored by Daiichi Sankyo.
NCT01014624 is a Phase 4 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 56 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01014624, a Phase 4 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 56 participants
- Enrollment target
Study Summary
The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12 reaction units (PRU) and described by Kaplan Meier curves. The primary analysis is descriptive and is intended to provide information relating to the return of baseline platelet function following discontinuation of maintenance therapy with either prasugrel or clopidogrel.
Primary Outcome
On the first day of the Washout Period (Visit 3), the blood draw for platelet function testing was obtained 24 hours (+/- 6 hours) after the last dose of study medication. Following Visit 3, platelet function testing was performed during each visit of the Washout Period until the participant met the following exit criteria: (Baseline PRU-PRU) less than or equal to 60 units and (Baseline PRU-PRU)/(Baseline PRU) less than or equal to 20%. The results are expressed as cumulative percentage of parti
Interventions
- DRUG Clopidogrel
- DRUG Prasugrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2010-02 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT01014624 record still lists
NCT01014624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT01014624 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01014624 about?
NCT01014624 is a clinical study titled "Prasugrel/Clopidogrel Maintenance Dose Washout Study". The primary objective of the study is to describe the cumulative proportion of participants who return to baseline platelet P2Y12 receptor function over time (up to 12 days post last maintenance dose) following discontinuation of prasugrel 10 mg daily x 7 days assessed by Accumetrics VerifyNow P2Y12...
What is the current status of trial NCT01014624?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 56 participants. The study started on 2010-02. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01014624?
The interventions under investigation include: Clopidogrel (DRUG), Prasugrel (DRUG).
Who is sponsoring clinical trial NCT01014624?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01014624's enrollment target sits among peer trials
56 1213th of 2000 higher than 783 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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