comparison of genetic make up based warfarin dose versus the standard dose of warfarin in asian patients
- Conditions
- Health Condition 1: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets
- Registration Number
- CTRI/2022/07/043907
- Lead Sponsor
- Amol N Patil
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 <30ml/min),
Pregnant or nursing women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent time spent in therapeutic range [ Denominator will be total observation time/ follow up time] <br/ ><br>Number of PT/INR investigations required <br/ ><br>Timepoint: Baseline, Day 30, Day 60, Day 90 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Dose titrations needed within 3 months <br/ ><br>Time taken to achieve stable INR [ minimum 2 serial INR values in the target range] <br/ ><br>events-free time in 3 months follow up [ bleeding and overt coagulation associated medical events] <br/ ><br>Major bleed complications <br/ ><br>composite [ all cause] deaths <br/ ><br>Hospitalization requirement <br/ ><br>Intensive care unit facility requirement <br/ ><br>Emergency visits <br/ ><br>Cost of the treatment and Cost effectiveness <br/ ><br>Timepoint: Baseline, Day 30, Day 60, Day 90 <br/ ><br>