Pharmacoeconomic analysis of warfarin therapy
- Conditions
- Health Condition 1: I348- Other nonrheumatic mitral valve disordersHealth Condition 2: null- Patients requiring Warfarin Therapy
- Registration Number
- CTRI/2017/08/009274
- Lead Sponsor
- King Edward Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
1.Patients who are to be freshly started on warfarin treatment (naive) for atleast 3 months for various Cardiovascular indications. These are the following indications but not limited to
a. Patient with valvular heart disease with atrial fibrillation/atrial flutter
b.Nonvalvular atrial fibrillation with CHADVAS score >1
c.Patient with deep vein thrombosis, Pulmonary embolism requiring anticoagulation
d. Dialated Cardiomyopathy with atrial fibrillation
e. Hypertrophic Cardiomyopathy with atrial fibrillation
f.Patients with documented thrombus in the left ventricular cavity
g.Patients having chocked valve who have to undergo mechanical valve prosthesis
2.Aged 18 years and above of either gender
3.Patients willing to give voluntarily written informed consent
4.Patient willing to comply with protocol requirements
1. Genotype (CYP2C9 and VKORC1) known to participant from prior testing or available in medical record
2.Pregnancy or lactation
3.Patients having history of renal and liver insufficiency
4.Any other clinical condition as per physicianâ??s judgment which compromises safety of the participant or credibility of the data.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incremental cost effectiveness ratio of genotyping as compared to standard INR based dose adjustment.Timepoint: 90 days follow up
- Secondary Outcome Measures
Name Time Method Comparison of mean time in therapeutic range (TIR) between two groups <br/ ><br> <br/ ><br>Timepoint: 90 days