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NCT02212028 · ClinicalTrials.gov registry record · Phase 4
Pharmacological Effects of Crushing Prasugrel in STEMI Patients
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 52
- Enrollment target
NCT02212028: Completed Phase 4 study, sponsored by University of Florida.
NCT02212028 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 52 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02212028, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 52 participants
- Enrollment target
Study Summary
Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of 60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its antiplatelet effects in this particular setting has been consistently shown. administration of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater bioavailability compared to the whole tablets has been observed. However, if the administration of a crushed prasugrel LD may overcome the above limitation is still unknown and represents the aim of our study. The proposed investigation will have a prospective, randomized, design in which STEMI patients undergoing primary PCI will be randomized to receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed tablets). Pharmacodynamic testing will be performed at several time points to test our study hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory effects.
Primary Outcome
The primary end-point of the study is the comparison in platelet reactivity expressed as PRU determined by VerifyNow P2Y12 between prasugrel 60 mg and crushed prasugrel 60 mg at 2 hours after LD administration
Interventions
- DRUG prasugrel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-10 |
| Est. Completion | 2015-08 |
| Phase | Phase 4 |
What the finished NCT02212028 record still lists
NCT02212028 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which prasugrel is the first listed.
NCT02212028 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02212028 about?
NCT02212028 is a clinical study titled "Pharmacological Effects of Crushing Prasugrel in STEMI Patients". Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of 60 mg loading dose (LD) foll...
What is the current status of trial NCT02212028?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 52 participants. The study started on 2014-10. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02212028?
The interventions under investigation include: prasugrel (DRUG).
Who is sponsoring clinical trial NCT02212028?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02212028's enrollment target sits among peer trials
52 1233rd of 2000 higher than 752 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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