Personalized Warfarin Dosing by Genomics and Computational Intelligence

NCT00872079 | Terminated Results

• 1 other identifier: CAMM-04-07S
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

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, the investigators 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, the investigators will test the program in patients that actually need this drug. They 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.

Conditions

Venous Thrombosis; Atrial Fibrillation; Myocardial Infarction

Keywords

warfarin; pharmacokinetics; pharmacodynamics

Outcome Measures

Primary Outcomes (1)

• Patient Genomics

  During Aim 2, Determined Patient Genotypes: CYP2C9 and VKORC1.

  Baseline

Study Arms (1)

Genomics

ACTIVE COMPARATOR

Aim 1: Collect historical data on warfarin dosing in subjects at the VA. Aim 2: Collect genotype information on up to 300 subjects receiving warfarin anticoagulation. Aim 3: Develop a computer model incorporating the information from Aim 1 and 2. Aim 4: Conduct randomized clinical trial.

Device: Genomics

Interventions

Genomics DEVICE

Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an international normalized ratio (INR) value within a specific target range.

Genomics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Warfarin therapy
• Attend anticoagulation clinic
• Warfarin therapy for 6 months

You may not qualify if:

• History of non-compliance

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Louisville

Louisville, Kentucky, 40206, United States

Location

MeSH Terms

Conditions

Venous Thrombosis; Atrial Fibrillation; Myocardial Infarction

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Infarction; Ischemia; Necrosis

Results Point of Contact

• Title: Michael Brier
• Organization: University of Louisville

mbrier@louisville.edu

502-852-0246

Study Officials

• Michael E. Brier, PhD

  VA Medical Center, Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 31, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: February 24, 2014
• Results First Posted: February 24, 2014

Record last verified: 2014-02

Locations

US (1)