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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: Clinical Trial Phase 3 study, sponsored by Artivion.
NCT04142658 is a Phase 3 study that was terminated before completion, run by Artivion. The registered enrollment target is 863 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Valve thrombosis was defined as any thrombus, not caused by infection, attached to or near an implanted On-X valve that occluded part of the blood-flow path, interfered with valve function, or was sufficiently large to warrant treatment other than continued oral anticoagulation. Valve-related thromboembolism was defined as any thromboembolic stroke, transient ischemic attack, myocardial infarction, or arterial thromboembolism to an organ or limb that was not associated with infection or an intra
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 |
Why NCT04142658 stopped before completion
NCT04142658 is an interventional study that assigns participants to a tested intervention. The registered 863 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 4 interventions - of which Warfarin is the first listed.
NCT04142658 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04142658's enrollment target sits among peer trials
863 380th of 2000 higher than 1,621 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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