Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Status:
Unknown status
Trial end date:
2008-05-01
Target enrollment:
Participant gender:
Summary
The study goal is to conduct a randomized controlled trial to compare safety and accuracy of
dosing based on clinical information including the clinical reason for your taking coumadin,
your age, gender, your body surface area, and other medical conditions you may have with
dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing
variability including genotypes for genes important in Coumadin metabolism and response. The
hypothesis to be tested by this trial states that:when compared to patients managed with a
best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin
dosing based on genetically programmed metabolic capacity and other known clinical and
environmental factors affecting dose will: 1)show reduced risk of adverse events (using
surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.