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Status unknownNCT00484640Updated Jun 11, 2007

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

An interventional study of Coumadin in Atrial Fibrillation, Deep Venous Thrombosis and Heart Valve Replacement, sponsored by Agency for Healthcare Research and Quality (AHRQ). Status unknown at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2007-06-11.

Sponsored by Agency for Healthcare Research and Quality (AHRQ) · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2007), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

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.

Read the 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

02

Conditions studied

  • Atrial Fibrillation
  • Deep Venous Thrombosis
  • Heart Valve Replacement
  • Pulmonary Embolism
03

In context

Pulmonary Embolism

739 studies on the registry are indexed under Pulmonary Embolism; 159 are open to participants now.

This study's planned enrollment of 260 is above the median of 150 across 381 interventional studies indexed under Pulmonary Embolism.

Browse Pulmonary Embolism studies →

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ) is the lead sponsor of 32 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Caucasian male and female patients(including Hispanic white) greater than or equal to 40 years of age;
  • Patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
  • Target INR of 2 to 3.5;
  • Women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.

Exclusion criteria

Exclusion Criteria:

  • Age less than 40 years;
  • Patients of known Native American, Asian, or African descent;
  • Patients with thrombocytopenia(platelet count\<50x10 cells/ml);
  • Patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
  • Patients with severe to moderate hepatic insufficiency (AST or ALT less than 2x the upper limit of normal;
  • Clinical contraindication for coumadin therapy;
  • Female patients with a positive pregnancy test or women who are breastfeeding
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
260 participants (estimated)

Interventions

  • DrugCoumadin
06

What researchers measure

Primary outcomes

  1. weighted time in therapeutic range

  2. absolute deviation from clinically optimal dose

Secondary outcomes

  1. time to stable dose in therapeutic target range

  2. warfarin related adverse drug events

  3. time to first INR above 4

07

Study locations

2 sites
  • Third Wave Molecular Diagnostics
    Madison, Wisconsin 53719, United States
    • Amy Brower, PhD · Sub investigator
  • Marshfield Clinic
    Marshfield, Wisconsin 54449, United States
08

References and documents

Publications

  • Hillman MA, Wilke RA, Caldwell MD, Berg RL, Glurich I, Burmester JK. Relative impact of covariates in prescribing warfarin according to CYP2C9 genotype. Pharmacogenetics. 2004 Aug;14(8):539-47. doi: 10.1097/01.fpc.0000114760.08559.dc. PubMed 15284536 ↗
  • Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14. PubMed 15596953 ↗
  • Wilke RA, Berg RL, Vidaillet HJ, Caldwell MD, Burmester JK, Hillman MA. Impact of age, CYP2C9 genotype and concomitant medication on the rate of rise for prothrombin time during the first 30 days of warfarin therapy. Clin Med Res. 2005 Nov;3(4):207-13. doi: 10.3121/cmr.3.4.207. PubMed 16303885 ↗
  • Hillman MA, Wilke RA, Yale SH, Vidaillet HJ, Caldwell MD, Glurich I, Berg RL, Schmelzer J, Burmester JK. A prospective, randomized pilot trial of model-based warfarin dose initiation using CYP2C9 genotype and clinical data. Clin Med Res. 2005 Aug;3(3):137-45. doi: 10.3121/cmr.3.3.137. PubMed 16160068 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00484640
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborators
Marshfield Clinic Research Foundation
First posted
Jun 11, 2007
Start date
Jun 2007
Completion
May 2008 (estimated)
Last update
Jun 11, 2007

Study contacts

Deborah J Hilgemann, Res. Coord.
Contact
hilgemann.deborah@marshfieldclinic.org
715-389-3774 ext. same
Sandra K Strey, Res. Coord.
Contact
strey.sandra@marshfieldclinic.org
715-389-4030 ext. same
Michael Caldwell, Physician
principal investigator · Marshfield Clinic Research Foundation

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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