The Home INR Study
Completed · Phase 4
Conditions studied: Atrial Fibrillation
In brief
Since home monitors of prothrombin time (PT) may potentially improve the safety, quality, and convenience of chronic anticoagulation management, it is likely that there will be demands from providers, patients, and manufacturers to make home monitors available to VA patients. The rationale for patient self-testing (PST) is that, compared to conventional high quality anticoagulation management (HQACM), it would permit more intense monitoring and increased patient participation in his/her own care, resulting in increased precision in anticoagulation control and thus fewer events of thromboembolism (strokes) and bleeding. The secondary hypothesis is that PST and HQACM will be comparable in terms of health care utilization and cost.
Key facts
- Study ID
- NCT00032591
- Run by
- US Department of Veterans Affairs
- People needed
- 2922
- Starts
- 2003-08-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2014-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To be enrolled in this study, patients must:
- have AF and/or a MHV;
- be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
- be using warfarin according to the criteria described in the Coumadin package insert (no off-label uses);
- be expected to survive for the duration of the study;
- not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the Coumadin package insert;
- be willing to perform PST;
- be willing to be randomized;
- possess adequate cognitive and language skills to follow the protocol and all related instructions;
- be willing to participate for the full duration of the study;
- sign the informed consent form; and
- not be enrolled in another randomized clinical trial that involves a drug or device intervention.
You may not qualify if…
- Patients are excluded in this study if:
- subject has had intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke, or any other absolute/major contraindication described in the warfarin package insert within the last month
- subject enrolled in another randomized clinical trial that involves a drug or device intervention
- subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
Where it is running
- VA Medical Center, Birmingham — Birmingham, Alabama, United States
- VA Central California Health Care System, Fresno — Fresno, California, United States
- VA Medical Center, Loma Linda — Loma Linda, California, United States
- VA Palo Alto Health Care System — Palo Alto, California, United States
- VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
- VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
- VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
- Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
- VA Medical Center, North Chicago — North Chicago, Illinois, United States
- VA Medical Center, Iowa City — Iowa City, Iowa, United States
- VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
- John D. Dingell VA Medical Center, Detroit — Detroit, Michigan, United States
- VA Medical Center, Minneapolis — Minneapolis, Minnesota, United States
- VA Medical Center, Kansas City MO — Kansas City, Missouri, United States
- Las Vegas — North Las Vegas, Nevada, United States
- VA Sierra Nevada Health Care System — Reno, Nevada, United States
- VA Western New York Healthcare System at Buffalo — Buffalo, New York, United States
- VA Medical Center, Syracuse — Syracuse, New York, United States
- VA Medical Center, Bronx — The Bronx, New York, United States
- Durham VA Medical Center HSR&D COE — Durham, North Carolina, United States
- VA Medical Center, Cleveland — Cleveland, Ohio, United States
- VA Medical Center, Oklahoma City — Oklahoma City, Oklahoma, United States
- VA Pittsburgh Health Care System — Pittsburgh, Pennsylvania, United States
- VA Medical Center, Providence — Providence, Rhode Island, United States
- VA North Texas Health Care System, Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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