CryoLife PROACT Xa (Mechanical Heart Valves) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if apixaban or warfarin works better to prevent blood clotting in people who have mechanical heart valves.

What is the Condition Being Studied?

Blood clotting in mechanical heart valve patients

Who Can Participate in the Study?

Adults who:
- Have an On-X mechanical heart valve
- Take medication to manage blood clotting

Age Group

What is Involved?

If you choose to be in this study, you will:
- Be randomly assigned (like flipping a coin) to 1 of 2 groups
-- Group 1: Take warfarin
-- Group 2: Take apixaban
- Have monthly phone calls
- Return to our clinic annually for up to 2 years for vital signs and blood draws

Study Details

Full Title
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
Principal Investigator
Protocol Number
IRB: PRO00104758
Phase N/A
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center