Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System

Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or mechanical cardiac valve replacement, prevention or treatment of venous thromboembolism (deep vein thrombosis and pulmonary embolism), to prevent thromboembolic events post-myocardial infarction, and in patients with systemic embolic events. Currently the only approved oral medication for anticoagulation is warfarin (Coumadin, Bristol-Myers Squibb and generic warfarin. Dosage is controlled by periodic determinations of the prothrombin time (PT)/International Normalized Ratio (INR). Under treatment may lead to venous or arterial thrombotic events or stroke, while over treatment may lead to major bleeding and even death. Patients require frequent INR monitoring to maintain a therapeutic level of anticoagulation. The therapeutic INR range varies by clinical indication, most commonly an INR 2-3 goal, but ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of 4.0. The vMetrics - Anticoagulation Management System is a remote patient management solution for Oral Anticoagulation Care patients. This system provides confirmation of patient question and testing protocols as well as virtual patient management care capability for dosage and patient scheduling. This trial will provide end points to ascertain efficiency against standard care protocol and confirm equivalent care standards.