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

NCT00484640 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2007-06-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Coumadin

Sponsors & Collaborators

  • Marshfield Clinic Research Foundation

    collaborator OTHER

  • Agency for Healthcare Research and Quality (AHRQ)

    lead FED

Principal Investigators

  • Michael Caldwell, Physician · Marshfield Clinic Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Completion
2008-05-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484640 on ClinicalTrials.gov