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|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|
|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|
|Inclusions: ||Patients requiring isolated aortic valve replacement (AVR) or|
Isolated mitral valve replacement (MVR)
Concomitant cardiac surgery is allowed
|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
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|