Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Public ClinicalTrials.gov record NCT00978445. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Use of a Novel Remote Home PT/INR-monitoring Device for Long-Term Anticoagulation Management
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00978445
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2009
- Primary completion
- Jul 31, 2010
- Completion
- Jul 31, 2010
- Last update posted
- Mar 20, 2013
2009 – 2010
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cleveland Clinic main campus | Cleveland | Ohio | 44195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00978445, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 20, 2013 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00978445 live on ClinicalTrials.gov.