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Prospective Randomized On-X Valve Anticoagulation Clinical Trial

Summary of Trial: 
The purpose of this study is to determine whether or not patients with the On-X valve can be maintained on either a lower dose of Coumadin or Plavix and aspirin.
Principal Investigator:Dr. Duke E. Cameron
Study Coordinator:Kimberly Behrens, RN, BSN
(410) 502-1914
Study Long Title: Prospective Randomized On-X Valve Anticoagulation Clinical Trial
Study Short Title: PROACT Study
JHU eIRB Number:NA_00026073
Funding Source:Medical Carbon Research Institute, LLC

Patients requiring isolated aortic valve replacement (AVR) or
Isolated mitral valve replacement (MVR)
Concomitant cardiac surgery is allowed
Adult patients



Right side valve surgery
Double (aortic plus mitral) valve replacement
Patients with active endocarditits at the time of implant
Previous confirmed or suspected thromboembolic event or thrombophlebitis occurring or resolving within the last year prior to enrollment
Other terminal illness
Patients who are in an emergency state
Inability to return for required follow-ups
Patients with an On-X valve implanted with the study and subsequently explanted
Patients who are known to be pregnant, plan to become pregnant or are lactating
Patients with acquired immunodeficiency syndrome or known HIV positive
Patients who are prison inmates or known drug or alcohol abusers
Patients unable to give adequate informed consent
Clinical Trial Site:  

Johns Hopkins Hospital
1800 Orleans Street
Sheikh Zayed Tower
Suite 7107
Baltimore, MD 21287

This is a multi-center study.  There are 26 sites across the U.S. that are participating in this clinical trial.
Start Date:July 2009
Anticipated End Date:N/A
Compensation for Participating: None



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