Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing

Atrial Fibrillation Clinical Trial

Official title: Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing

Status Unknown status

Clinical Trial 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.

Clinical Trial Description

The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including clinical reason for taking coumadin, your age, gender, your body surface area, and other medical conditions you may have and dosing 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 ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Venous Thrombosis
• Embolism
• Heart Valve Replacement
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

• NCT number: NCT00484640
• Study type: Interventional
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: Deborah J Hilgemann, Res. Coord.
• Phone: 715-389-3774
• Email: hilgemann.deborah@marshfieldclinic.org
• Status: Unknown status
• Phase: N/A
• Start date: June 2007
• Completion date: May 2008