A study to assess the effect of patient related factors on warfarin dosing.

Completed

Conditions: cardiovascular disease patients recieving warfarin therapy

Registration Number: CTRI/2015/12/006455

Lead Sponsor: Ramakanth GSH

Brief Summary: Warfarintherapy is widely used for the prevention of thromboembolic events for avariety of medical conditions. The goal of anticoagulant therapy with warfarin is toadminister the lowest effective dose of the drug to maintain the targetinternational normalized ratio (INR). Thedosing of warfarin is patient-specific. The initiation and maintenance of warfarin therapy is based on the international normalized ratio (INR) levels. Also, the safety and efficacy of warfarin therapy aredependent on maintaining the INR within the target range for the indication. Warfarin dose may be variable which can be explained,to some extent, by concomitant medications, gender, nutritional status, liverdisease, alcohol consumption, diarrhea, hyperthyroidism, fever, chronic heartfailure (CHF), and, ethnicity. Warfarinhas a narrow therapeutic window and has been associated with many drug-drug anddrug-food interactions. However, little evidence is available concerning theimpact of other factors, such as body mass index (BMI) and vitamin K intake. Clearlydefined effects of patient factors on warfarin dose may better facilitateachievement of therapeutic INRs following initiation of warfarin therapy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 100

Inclusion Criteria

Patients of either sex in age group between 18 to 65 years on warfarin therapy with INR between 2 to 3.5 and with stable total warfarin maintenance dose for three consecutive months will be included for the study.

Exclusion Criteria

Patients with INR outside the range of 2 to 3.5 and non-compliant to warfarin therapy and study procedure will be excluded from the study.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of oneâ€“week vitamin K intake on total weekly warfarin dose	1 week

Secondary Outcome Measures

Name	Time	Method
Evaluation of data collected on age, gender and tobacco &/or alcohol consumption on total weekly warfarin dose	1 week

Trial Locations

Locations (1): Nizams Institute of Medical Sciences
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Nizams Institute of Medical Sciences
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Ramakanth GSH
Principal investigator
9703633788
grk234@yahoo.co.in