The Home INR Study
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Weekly patient self-testing of prothrombin time; High quality anticoagulation management (HQACM) with conventional monthly testing
Intervention description: HQACM with testing every 4 weeks and as indicated for out of range values, medication/clinical changes.
Intervention MeSH terms: Thrombin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2922.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AF; Mechanical heart valve (MHV)

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

        To be enrolled in this study, patients must:

          1. have AF and/or a MHV;

          2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);

          3. be using warfarin according to the criteria described in the Coumadin package insert
             (no off-label uses);

          4. be expected to survive for the duration of the study;

          5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid
             hemorrhage, hemorrhagic stroke) or any other contraindication described in the
             Coumadin package insert;

          6. be willing to perform PST;

          7. be willing to be randomized;

          8. possess adequate cognitive and language skills to follow the protocol and all related
             instructions;

          9. be willing to participate for the full duration of the study;

         10. sign the informed consent form; and

         11. not be enrolled in another randomized clinical trial that involves a drug or device
             intervention.

        Exclusion Criteria:

        Patients are excluded in this study if:

          1. 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

          2. subject enrolled in another randomized clinical trial that involves a drug or device
             intervention

          3. subject is not able to follow the protocol and all related instructions, and does not
             have a caregiver with these skills