Please select the eligibility criteria that correspond to the clinical trial below.
Title: Evaluation of Self-monitoring of Oral antiCoagulant therApy by the PatiEnts
Brief Summary: The purpose of this study is to determine whether self-management of oral anticoagulation therapy with warfarin has an effect on patient's quality of life following a specific training program led by pharmacists.


Options:
A: Inclusion criteria:

1. Patients aged 18-75
2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

1. Prior valve surgery
2. Uncontrolled hypertension
3. severe renal impairment
4. active liver disease
5. increased risk of bleeding
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:

* 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
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: C