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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 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 81 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04483583
The ClinicalTrials.gov registry entry for NCT04483583 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Clopidogrel is the first listed.
NCT04483583 reports 0 study locations.
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.
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