Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.
• Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).
• AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group:
‣ Chronic atrial fibrillation
⁃ Left ventricular ejection fraction \< 30 %
⁃ Enlarged left atrium \>50mm diameter
⁃ Spontaneous echo contrasts in the left atrium
⁃ Vascular pathology
⁃ Neurological events
⁃ Hypercoagulability
⁃ Left or right ventricular aneurysm
⁃ Lack of platelet response to aspirin or clopidogrel
⁃ Women receiving estrogen replacement therapy
• Concomitant cardiac surgery is allowed
• Adult patients