Cardiac Surgery - PROACT Xa

This is a prospective, multicenter, open-label, randomized active controlled clinical trial to determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for the primary composite outcome of valve thrombosis and valve-related thromboembolism in patients with an On-X mechanical heart valve implanted in the aortic position

Dr. Robert Hagberg with the Department of Cardiac Surgery is the primary investigator for this study. Participants will be randomized to either continue warfarin with a target INR of 2.0 to 3.0 or switch to apixaban 5 mg twice daily (BID), or 2.5 mg BID.  Approximately 1000 participants will be randomly assigned to study intervention with an estimated total of 500 participants in the apixaban arm and 500 participants in the warfarin arm.

Eligibility Criteria:

• 18 years of age
• able to take Warfarin and low-dose Aspirin and
• implantation of an On-X mechanical valve at least 90 days prior to patient enrollment.

Please contact Cynthia Marques at 860-972-5798 or email Cynthia.marques@hhchealth.org for more information