| 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 Email: kbehren1@jhmi.edu (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 |
| Inclusions: | Patients requiring isolated aortic valve replacement (AVR) or Isolated mitral valve replacement (MVR) Concomitant cardiac surgery is allowed Adult patients |
Exclusions: | 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 600 North Wolfe Street, Blalock 618 Baltimore, MD 21287-4618 This is a multi-center study. There are 25 additional 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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