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:

* 21 years of age or older; male or female.
* Able to provide written informed consent.
* History of documented AF within the prior 12 months
* A moderate to high risk of stroke, as defined by CHADS2 index score of at least 2

Exclusion Criteria:

* Transient atrial fibrillation secondary to other reversible disorders
* Subjects with moderate or severe mitral stenosis, unresected atrial myxoma, or a mechanical heart valve
* Subjects with any contraindication for anticoagulant agents;
* Subjects with conditions associated with high risk of bleeding or have known or suspected hereditary or acquired bleeding disorders
* Females of childbearing potential including the following:

  * Females with a history of tubal-ligation
  * Females less than 2 years post-menopausal
B: 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
C: Inclusion Criteria:

Patient inclusion criteria will be:

* 18 years of age or greater
* Admission to the internal medical or cardiology services at LAC/USC Medical Center
* Discharge directly from the medical service to home
* During admission, being evaluated or treated for congestive heart failure or coronary artery disease.

Patient Exclusion criteria :

* Moderate or severe cognitive dysfunction
* Severe psychiatric disability such that the patient has, or there is an application for, a conservator, or any psychiatric illness with current psychotic features
* Not having speaking proficiency in either English or Spanish language.
* If the patient was previously enrolled in the study on a prior hospitalization, he or she will also be excluded.

Nurse Inclusion Criteria:

* Performing the patient education at hospital discharge for a patient enrolled in the study
D: Inclusion Criteria:

* Patient aged 18 years and over followed at the Montreal Heart Institute's Anticoagulation clinic
* Warfarin treatment planned for at least 4 months after inclusion in the study
* Warfarin treatment initiated for at least 6 months
* Last 2 INRs between 1.5 and 4 if target INR is between 2 and 3
* Last 2 INRS between 2 and 4 if target INR is between 2.5 and 3.5
* Provide a signed informed consent

Exclusion Criteria:

* Patient unable to understand (spoken and written) French or English
* Patient refuses or is unable to attend the required training sessions
* Targeted INR other than 2 to 3 or 2.5 to 3.5
* Handicap or physical limitation compromising the patient's ability to initiate self-monitoring in the absence of a proxy helper
* Moderate to severe cognitive impairment or important comprehension problems
* Active neoplasm
* Concurrent chemotherapy
* Hypercoagulable conditions
* Life expectancy of less than 1 year documented in the medical chart
* Inclusion (at time of inclusion or 30 days prior to inclusion) in another research project involving a drug
* Patient anticoagulated with nicoumalone
* Pregnancy or breastfeeding
* Active bleeding (except for menses)
* Recent major bleeding (less than 3 months before inclusion)
* Stroke, acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft, cardiac valve replacement, deep veinous thrombosis or pulmonary embolism in the 3 months prior to inclusion
* Any other condition that, in the opinion of the investigators, of the treating physician or of the healthcare professionals working at the anticoagulation clinic could make self-management by the patient impossible

Answer: B