Health Condition 1: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adult patients (>=18years of age), of either sex with a diagnosis of atrial fibrillation, deep vein thrombosis, hematological malignancy, prosthetic/mechanical heart valve disease, or pulmonary/non-pulmonary thromboembolism, Newly started on warfarin or already receiving warfarin therapy, Able to give informed consent, Able to give follow-up for study purposes.
Exclusion criteria
Exclusion criteria: Patients with known contraindications to anticoagulation therapy, Patients with transient atrial fibrillation secondary to reversible disorders such as thyrotoxicosis, cardiothoracic surgery and severe anemia, Patients with underlying hepatic (defined as elevation in alanine/aspartate transaminase >2.5 times the upper limit of normal) and or severe renal insufficiency (demarcated as creatinine clearance of Pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent time spent in therapeutic range [ Denominator will be total observation time/ follow up time] Number of PT/INR investigations required Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Dose titrations needed within 3 months Time taken to achieve stable INR [ minimum 2 serial INR values in the target range] events-free time in 3 months follow up [ bleeding and overt coagulation associated medical events] Major bleed complications composite [ all cause] deaths Hospitalization requirement Intensive care unit facility requirement Emergency visits Cost of the treatment and Cost effectiveness Timepoint: Baseline, Day 30, Day 60, Day 90 | — |
Countries
India
Contacts
PGIMER