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Pharmacoeconomic analysis of warfarin therapy

Pharmacoeconomic study for cost effectiveness of Genotyping in patients on warfarin therapy with respect to prevention of bleeding episodes - PEPGx

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009274
Enrollment
300
Registered
2017-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I348- Other nonrheumatic mitral valve disorders Health Condition 2: null- Patients requiring Warfarin Therapy

Interventions

Intervention1: Warfarin: Warfarin dose based on genotype Control Intervention1: Warfarin: Warfarin dose based on non genotype

Sponsors

King Edward Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Incremental cost effectiveness ratio of genotyping as compared to standard INR based dose adjustment.Timepoint: 90 days follow up

Secondary

MeasureTime frame
Comparison of mean time in therapeutic range (TIR) between two groups Timepoint: 90 days

Countries

India

Contacts

Public ContactShital Bendkhale

King Edward Memorial Hospital

urmilathatte@gmail.com9820198462

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026