Artivion Inc. has halted the PROACT Xa clinical trial that was testing whether patients with an On-X mechanical aortic valve could be safely and effectively managed with the direct oral anticoagulant (DOAC) apixaban (Eliquis) rather than warfarin.
The decision to stop the trial was based on the recommendation of the independent data and safety monitoring board (DSMB), which cited a lack of evidence supporting noninferiority of apixaban over warfarin for valve thrombosis and thromboembolism.
Currently, warfarin is the only approved anticoagulant for patients with mechanical valves.
In the PROACT Xa trial, which began enrollment in April 2020, patients with an On-X mechanical aortic valve were randomly allocated to receive anticoagulation with warfarin or apixaban.
"The DSMB found that blood clots, resulting in stroke, occurred more frequently in patients receiving apixaban and that continuing the trial was unlikely to achieve the primary endpoint while possibly exposing patients to increased risk," Artivion said in a statement.
"The PROACT Xa trial was designed to determine whether apixaban would yield equivalent safety to the standard anticoagulant, warfarin. Unfortunately, it appears that it does not," John Alexander, MD, chair of the PROACT Xa trial and professor of medicine/cardiology at Duke University School of Medicine, Durham, North Carolina, said in the statement.
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Cite this: PROACT Xa Trial of Apixaban With On-X Heart Valve Stopped - Medscape - Sep 29, 2022.