NCT00484640

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Agency for Healthcare Research and Quality (AHRQ) · Federal
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

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

Interventions

Type	Name	Description
DRUG	Coumadin

Timeline

• Start date: 2007-06-01
• Completion: 2008-05-01
• First posted: 2007-06-11
• Last updated: 2007-06-11

Locations

2 sites across 1 country: United States