Celebrating 25 Years of Lung Transplants

PI: Craig Selzman, MD 

• Project: A prospective, randomized, active (warfarin) controlled, parallel-arm clinical trial to determine if patients with an On-X aortic valve can be maintained safely and effectively on the factor Xa inhibitor apixaban. 
• Background: There is an unmet clinical need for an alternative to warfarin, such as a direct oral anticoagulant (DOAC), as anticoagulation in patients with an aortic mechanical prosthetic valve. The primary objective is to determine if apixaban is superior to warfarin (INR 2.0-3.0) for patients with an On-X mechanical heart valve for the primary outcome of valve thrombosis and valve-related thromboembolism. 
• Study Design: Participants are eligible if they are at least 18 years of age, at least 3 months out from an On-X aortic valve implantation, and currently managing their anticoagulation with warfarin. If enrolled, they will be followed for 2 years. Participants will be randomized to either continue warfarin or switch to apixaban.

Participants randomized to apixaban will receive 5 mg twice daily (BID), or apixaban 2.5 mg BID in participants with 2 or 3 of the following characteristics:
•    age ≥ 80 years
•    weight ≤ 60 kilograms
•    creatinine ≥ 1.5 mg/dL (133 micromol/L)

For participants randomized to apixaban, INR testing will be performed on the current warfarin dose with the following algorithm to initiate apixaban:
1. INR < 2; stop warfarin and start apixaban
2. INR 2.0 to 3.0; hold warfarin for 2 days, start apixaban on day 3
3. INR > 3.0 to 4.0; hold warfarin for 4 days, start apixaban on day 5
4. INR > 4.0; hold warfarin for 2 days, recheck INR, refer to steps 1, 2, or 3

For more information: 

• Contact the study coordinator Chloe Skidmore
• NCT: 04142658