Personalized Warfarin Dosing by Genomics and Computational Intelligence
| Status: | Archived |
|---|---|
| Conditions: | Atrial Fibrillation, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2008 |
| End Date: | September 2011 |
Personalized Warfarin Dosing Using Genomics and Computational Intelligence
This study will create a computer program that can be used to help dose a drug called
warfarin for the prevention of blood clotting. The study will collected specific information
about those patients receiving this drug and use that information to create a computer
program that will predict the effects of the drug. With this prediction program in place we
can perform a series of "what if I gave this amount of drug" simulations to determine the
best dose of drug for that patient. Once the computer programs are developed we will test
the program in patients that actually need this drug. We will also include genetic
information into the prediction since it has been shown that this information can affect how
well the drug works. Patients will have this genetic information determined during this
study.
The objective of this project is to develop new techniques to incorporate genomic data into
pharmacodynamic models to improve the dosing of chronically administered drugs.
Specifically, we look to improve warfarin therapy by decreasing the variability in the
effect of this drug using information about the subjects genotype and computational
intelligence. We propose to achieve our objectives using a prospective, randomized,
controlled clinical trial of a computer program that we will develop from both historical
and prospective data. This computer program will be tested against a control group using
standard warfarin dosing, and a group using standard dosing plus subject genotype. Warfarin
dose and response data will be obtained from patients seen in the Louisville VA
anticoagulation clinic. Following informed consent, subject genotype for cytochrome P450 2C9
and VKORC1 will be determined. Other data routinely obtained to aid in warfarin dosing will
also be recorded. Using this information we will develop many different models for warfarin
dosing using incrementally more information. Each of these models will be tested using
computer simulation until we have obtained the best model. This model will be used in a
pilot study to test performance in real time. The results of the pilot study will then be
used to power a final clinical trial of standard dosing, standard dosing and genetic
information, computer dosing, and computer dosing plus genetic information.
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