Table 2 Schedule of enrolment, interventions, and assessments of the WARFA trial
STUDY FOLLOW-UP | |||||||||
|---|---|---|---|---|---|---|---|---|---|
Enrolment/ Randomization | 1st Month/ Period | 2nd Month/ Period | 3rd Month/ Period | 4th Month/ Period | |||||
WEEK | 0 | 3 | 4 | 7 | 8 | 11 | 12 | 15 | 16 |
ENROLMENT | |||||||||
Eligibility screen | X | ||||||||
Informed consent | X | ||||||||
Allocation | X | ||||||||
INTERVENTIONS | |||||||||
Assessment of INR variability | X | ||||||||
Switch of warfarin formulation | X | X | X | ||||||
ASSESSMENTS | |||||||||
Assessment of patient stability in warfarin treatment | X | ||||||||
INR | X | X | X | X | X | X | X | X | X |
PT | X | X | X | X | X | X | X | X | X |
Warfarin dosage | X | X | X | X | X | X | X | X | X |
Stroke | X | X | X | X | X | X | X | X | X |
Major Bleeding | X | X | X | X | X | X | X | X | X |
Death | X | X | X | X | X | X | X | X | X |
Systemic thromboembolism | X | X | X | X | X | X | X | X | X |
Minor bleeding | X | X | X | X | X | X | X | X | X |
Adherence | X | X | X | X | |||||