Assessing the Clinical Benefits of a Pharmacogenetics-Guided Dosing Regiment for Calculating Warfarin Maintenance Dose

• Status: Unknown status
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Interethnic differences in warfarin dose requirements in the Asian population have been well described. Our previous studies showed that warfarin maintenance doses in our multi-ethnic population were closely related to patient demographics and genetic polymorphisms in cytochrome(CYP)P4502C9 and vitamin K epoxide reductase complex subunit 1(VKORC1). A retrospective regression model combining these predictors accounts for 57.8% of the variability in warfarin dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Treatments: Warfarin

Criteria

Inclusion Criteria:

1. At least 18 years of age

2. New indication for warfarin therapy

3. No previous history of liver disease; transaminases must be less than 3 times upper limit of normal and bilirubin within normal range

4. No previous history of malabsorption syndrome or chronic diarrheal conditions

5. Written, informed consent

Exclusion Criteria:

1. Uncontrolled hypertension

2. Peptic ulcer disease

3. Any other medical conditions as deemed unfit for warfarin therapy based on clinical judgement of primary physician