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NCT04483583 · ClinicalTrials.gov registry record · Phase 4
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 81
- Enrollment target
NCT04483583: Completed Phase 4 study, sponsored by University of Florida.
NCT04483583 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 81 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04483583, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 81 participants
- Enrollment target
Study Summary
Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response to clopidogrel. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i.e., ticagrelor) may be considered in patients at increased thrombotic risk, they do not recommend routine testing to identify patients with poor response to clopidogrel. The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopidogrel vs ticagrelor) in patients at high risk for high platelet reactivity identified according to the ABCD-GENE score in PCI treated patients also requiring OAC. Up to a total of up to 63 patients are planned to be prospectively enrolled in this investigation which will entail a series of comprehensive pharmacodynamic assessments to reach the study aim.
Primary Outcome
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system of ticagrelor versus clopidogrel in patients with an ABCD-Gene score ≥10. A PRU \>208 suggests high platelet reactivity, while \<85 may indicate increased bleeding risk.
Interventions
- DRUG Clopidogrel
- DRUG Ticagrelor 60mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2020-12-08 |
| Est. Completion | 2025-01-07 |
| Phase | Phase 4 |
What the finished NCT04483583 record still lists
NCT04483583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT04483583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04483583 about?
NCT04483583 is a clinical study titled "Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI". Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response to clopidogrel. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i...
What is the current status of trial NCT04483583?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 81 participants. The study started on 2020-12-08. Estimated completion is 2025-01-07.
What interventions are being tested in trial NCT04483583?
The interventions under investigation include: Clopidogrel (DRUG), Ticagrelor 60mg (DRUG).
Who is sponsoring clinical trial NCT04483583?
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 NCT04483583's enrollment target sits among peer trials
81 940th of 2000 higher than 1,055 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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