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comparison of genetic make up based warfarin dose versus the standard dose of warfarin in asian patients

Derivation and validation of pharmacogenetically-guided warfarin dosing algorithm followed by comparison of the same pharmacogenetically guided versus standard of care warfarin therapy in asian indian population

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/07/043907
Enrollment
168
Registered
2022-07-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: Z790- Long term (current) use of anticoagulants and antithrombotics/antiplatelets

Interventions

Intervention1: Pharmacogenetically guided dose titration: DNA isolation for gene polymorphism detection from one time blood sample from patient on warfarin Control Intervention1: Standard of care: Pat

Sponsors

Amol N Patil
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactAishwarya Anand

PGIMER

seeamol83@gmail.com9990245973

Outcome results

None listed

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