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NCT02567461 · ClinicalTrials.gov registry record · Phase 4
Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel
A Phase 4 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT02567461 is a Phase 4 study that has completed, run by University of Florida. The registered enrollment target is 80 participants.
The verdict
NCT02567461, a Phase 4 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study Summary
It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).
Interventions
- DRUG Aspirin 81 mg
- DRUG Edoxaban 60 mg
- DRUG Edoxaban 30 mg
- DRUG Clopidogrel 75 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-03 |
| Est. Completion | 2018-03-15 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02567461
The ClinicalTrials.gov registry entry for NCT02567461 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 80 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 4 interventions - of which Aspirin 81 mg is the first listed.
NCT02567461 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02567461 about?
NCT02567461 is a clinical study titled "Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel". It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively....
What is the current status of trial NCT02567461?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2016-03. Estimated completion is 2018-03-15.
What interventions are being tested in trial NCT02567461?
The interventions under investigation include: Aspirin 81 mg (DRUG), Edoxaban 60 mg (DRUG), Edoxaban 30 mg (DRUG), Clopidogrel 75 mg (DRUG).
Who is sponsoring clinical trial NCT02567461?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
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