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NCT01260584 · ClinicalTrials.gov registry record · Phase 4
The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease
A Phase 4 study, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 4
- Development phase
- 110
- Enrollment target
NCT01260584: Completed Phase 4 study, sponsored by Daiichi Sankyo.
NCT01260584 is a Phase 4 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 110 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260584, a Phase 4 study, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 110 participants
- Enrollment target
Study Summary
This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites of clopidogrel. The primary hypothesis is that smoking status will influence the antiplatelet effects and active metabolite concentrations of clopidogrel but will have no impact on prasugrel's antiplatelet effects or active metabolite concentrations.
Primary Outcome
IPA will be measured by the Accumetrics P2Y12 Assay Device. Response will be assessed in P2Y12 Reaction Units and as Platelet Reactivity Index (vasodilator-stimulated phosphoprotein assay).
Interventions
- DRUG Clopidogrel
- DRUG Prasugrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2010-11 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
What the finished NCT01260584 record still lists
NCT01260584 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT01260584 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01260584 about?
NCT01260584 is a clinical study titled "The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease". This study is being conducted to determine if smoking will influence the platelet aggregation inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any effect on the plasma concentrations of the active metabolite of prasugrel and the active and inactive metabolites o...
What is the current status of trial NCT01260584?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 110 participants. The study started on 2010-11. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01260584?
The interventions under investigation include: Clopidogrel (DRUG), Prasugrel (DRUG).
Who is sponsoring clinical trial NCT01260584?
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 NCT01260584's enrollment target sits among peer trials
110 727th of 2000 higher than 1,264 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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