Artivion Stops PROACT Xa Clinical Trial Evaluating On-X Mechanical Valve With Apixaban
Written By: Adam Pick, Patient Advocate, Author & Website Founder
Page last updated: November 29, 2022
Artivion has stopped the PROACT Xa Clinical Trial evaluating the safety-and-effectiveness of the On-X mechanical valve with apixaban as a blood thinner to prevent clotting. The PROACT Xa clinical trial was designed to evaluate whether patients could safely receive an On-X mechanical valve without the lifelong monitoring requirements of warfain, the only approved blood thinner for mechanical valves.
On-X Aortic Mechanical Heart Valve
More specifically, the PROACT Xa Clinical trial was suspended following a recommendation of the independent Data and Safety Monitoring Board (DSMB). The PROACT Xa study was evaluating the use of apixaban (Eliquis) in patients treated with mechanical aortic valves. According to Market Insider, the recommendation by the DSMB of the trial was due to lack of evidence supporting non-inferiority of apixaban to warfarin for valve thrombosis and thromboembolism.
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.
Dr. John Alexander, Chair of the PROACT Xa trial and Professor of Medicine/Cardiology at Duke University School of Medicine, said, “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. On behalf of all of the investigators, we appreciate the research effort into the science of managing patients with artificial heart valves.”
Pat Mackin (Artivion CEO)
Pat Mackin, Chairman, President and Chief Executive Officer of Artivion said, “We are disappointed to stop the PROACT Xa trial as a successful trial would have significantly benefited patients.”
While the PROACT Xa Clinical Trial did not yield the result our patient community was hoping for, I want to acknowledge Artivion, the principal investigators, the research teams, and the patients who participated in this study.
Keep on tickin,