Atrial Fibrillation | HEART-VALVE, MECHANICAL
Item
1. have af and/or a mhv;
boolean
C0004238 (UMLS CUI [1])
C0493527 (UMLS CUI [2])
Warfarin Indefinite time
Item
2. be scheduled to receive warfarin indefinitely (operationally defined as 2 years);
boolean
C0043031 (UMLS CUI [1,1])
C0332187 (UMLS CUI [1,2])
Use of Warfarin | Coumadin Package Inserts
Item
3. be using warfarin according to the criteria described in the coumadin package insert (no off-label uses);
boolean
C1524063 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0699129 (UMLS CUI [2,1])
C0030174 (UMLS CUI [2,2])
Continuance of life Study duration
Item
4. be expected to survive for the duration of the study;
boolean
C0038952 (UMLS CUI [1,1])
C0489652 (UMLS CUI [1,2])
Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage
Item
5. not be suffering from intracranial bleeding (intracranial hemorrhage, subarachnoid hemorrhage, hemorrhagic stroke) or any other contraindication described in the coumadin package insert;
boolean
C0151699 (UMLS CUI [1])
C0038525 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
Patient Self Testing
Item
6. be willing to perform pst;
boolean
C0030705 (UMLS CUI [1,1])
C0036588 (UMLS CUI [1,2])
C0039593 (UMLS CUI [1,3])
Randomization
Item
7. be willing to be randomized;
boolean
C0034656 (UMLS CUI [1])
Compliance behavior | Skills relating to cognitive functions | language ability
Item
8. possess adequate cognitive and language skills to follow the protocol and all related instructions;
boolean
C1321605 (UMLS CUI [1])
C0589520 (UMLS CUI [2])
C1145677 (UMLS CUI [3])
Study Subject Participation Status
Item
9. be willing to participate for the full duration of the study;
boolean
C2348568 (UMLS CUI [1])
Informed Consent
Item
10. sign the informed consent form; and
boolean
C0021430 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures
Item
11. not be enrolled in another randomized clinical trial that involves a drug or device intervention.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1948041 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C1948041 (UMLS CUI [3,2])
Intracranial Hemorrhages | Subarachnoid Hemorrhage | Brain hemorrhage | Medical contraindication
Item
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
boolean
C0151699 (UMLS CUI [1])
C0038525 (UMLS CUI [2])
C0553692 (UMLS CUI [3])
C1301624 (UMLS CUI [4])
Study Subject Participation Status | Investigational New Drugs Surgical and medical procedures | Investigational Medical Device Surgical and medical procedures
Item
2. subject enrolled in another randomized clinical trial that involves a drug or device intervention
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C1948041 (UMLS CUI [2,2])
C2346570 (UMLS CUI [3,1])
C1948041 (UMLS CUI [3,2])
Compliance behavior Limited
Item
3. subject is not able to follow the protocol and all related instructions, and does not have a caregiver with these skills
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])