The Home INR Study (THINRS)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring AF, Mechanical heart valve (MHV)
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- VA Medical Center, Birmingham
- VA Central California Health Care System, Fresno
- VA Medical Center, Loma Linda
- VA Palo Alto Health Care System
- VA Greater Los Angeles Healthcare System, West LA
- VA Eastern Colorado Health Care System, Denver
- VA Connecticut Health Care System (West Haven)
- Edward Hines, Jr. VA Hospital
- VA Medical Center, North Chicago
- VA Medical Center, Iowa City
- VA Maryland Health Care System, Baltimore
- John D. Dingell VA Medical Center, Detroit
- VA Medical Center, Minneapolis
- VA Medical Center, Kansas City MO
- Las Vegas
- VA Sierra Nevada Health Care System
- VA Medical Center, Bronx
- VA Western New York Healthcare System at Buffalo
- VA Medical Center, Syracuse
- Durham VA Medical Center HSR&D COE
- VA Medical Center, Cleveland
- VA Medical Center, Oklahoma City
- VA Pittsburgh Health Care System
- VA Medical Center, Providence
- VA North Texas Health Care System, Dallas
- VA South Texas Health Care System, San Antonio
- VA Medical Center, Salem VA
- Wlliam S. Middleton Memorial Veterans Hospital, Madison
- VA Medical Center, San Juan
Arms of the Study
Arm 1
Arm 2
Active Comparator
Other
Arm 1
Arm 2
Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
High quality anticoagulation management (HQACM) with conventional monthly testing