Please select the eligibility criteria that correspond to the clinical trial below.
Title: CSP #481 - The Home INR Study (THINRS)
Brief 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.


Options:
A: Inclusion Criteria:

* Over 18 years of age
* Anticoagulation to a target of 2.0-3.0
* Warfarin treatment for \> 3 months
* previous medication treatment adherence
* competence judged by demonstrable ability to utilize drug adjustment nomograms
* understand the basic theory of anticoagulation therapy

Exclusion Criteria:

* Coagulopathic disease
* significant psychiatric illness
* significant language barrier
* poor visual acuity
B: Inclusion criteria:

1. Completed study 1160.113 per protocol
2. Continuing need for anticoagulation

Exclusion criteria:

1. uncontrolled hypertension
2. severe renal impairment
3. active liver disease
4. increased risk of bleeding
C: Inclusion Criteria:

* Patients that received a mechanical valve while in our hospital
* Age \> 18 years

Exclusion Criteria:

* Pregnant or lactating women
* Patients that have genetic clotting disorders such as Factor 5
* Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)
D: 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

Answer: D