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NCT04142658 · ClinicalTrials.gov registry record · Phase 3
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
A Phase 3 study, sponsored by Artivion.
- Terminated
- Registry status
- Phase 3
- Development phase
- 863
- Enrollment target
NCT04142658 is a Phase 3 study that was terminated before completion, run by Artivion. The registered enrollment target is 863 participants.
The verdict
NCT04142658, a Phase 3 study, was terminated before completion, sponsored by Artivion.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 863 participants
- Enrollment target
Study Summary
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.
Interventions
- DRUG Warfarin
- DRUG Apixaban 2.5 MG
- DRUG Apixaban 5 MG
- DEVICE On-X Aortic Mechanical Valve
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 863 participants |
| Start Date | 2020-05-01 |
| Est. Completion | 2022-12-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04142658
The ClinicalTrials.gov registry entry for NCT04142658 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 863 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Artivion, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Warfarin is the first listed.
NCT04142658 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04142658 about?
NCT04142658 is a clinical study titled "PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban". Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaba...
What is the current status of trial NCT04142658?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 863 participants. The study started on 2020-05-01. Estimated completion is 2022-12-12.
What interventions are being tested in trial NCT04142658?
The interventions under investigation include: Warfarin (DRUG), Apixaban 2.5 MG (DRUG), Apixaban 5 MG (DRUG), On-X Aortic Mechanical Valve (DEVICE).
Who is sponsoring clinical trial NCT04142658?
This trial is sponsored by Artivion, which has 7 total clinical trials registered on ClinicalTrials.gov.
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