NCT04142658Phase 3Terminated

PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2022-12-12Actual

Enrollment · participants863Actual

Source updated2024-03-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Aortic Valve Disease; Aortic Valve Stenosis; Aortic Valve Failure

Treatments or interventions studied

Apixaban 5 MGDrug
Apixaban 2.5 MGDrug
WarfarinDrug

Primary outcomes · main study measures

Read the study measures

measure: Composite of Valve Thrombosis and Valve-related Thromboembolism; description: 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 intracardiac tumor and was definitely or possibly related to the valve.; timeFrame: through study closure, a median follow-up of 13.5 months; measure: Major Bleeding; description: Major bleeding defined as any episode of internal or external bleeding that caused death, hospitalization, or permanent injury or necessitated transfusion, pericardiocentesis, or reoperation.; timeFrame: through study closure, a median follow-up of 13.5 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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