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

Primary Purpose

Atrial Fibrillation, Deep Venous Thrombosis, Heart Valve Replacement

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coumadin
Sponsored by
Agency for Healthcare Research and Quality (AHRQ)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  • 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

Sites / Locations

  • Third Wave Molecular Diagnostics
  • Marshfield Clinic

Outcomes

Primary Outcome Measures

weighted time in therapeutic range
absolute deviation from clinically optimal dose

Secondary Outcome Measures

time to stable dose in therapeutic target range
warfarin related adverse drug events
time to first INR above 4

Full Information

First Posted
June 4, 2007
Last Updated
June 8, 2007
Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborators
Marshfield Clinic Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00484640
Brief Title
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Official Title
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborators
Marshfield Clinic Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Deep Venous Thrombosis, Heart Valve Replacement, Pulmonary Embolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Coumadin
Primary Outcome Measure Information:
Title
weighted time in therapeutic range
Title
absolute deviation from clinically optimal dose
Secondary Outcome Measure Information:
Title
time to stable dose in therapeutic target range
Title
warfarin related adverse drug events
Title
time to first INR above 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah J Hilgemann, Res. Coord.
Phone
715-389-3774
Ext
same
Email
hilgemann.deborah@marshfieldclinic.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra K Strey, Res. Coord.
Phone
715-389-4030
Ext
same
Email
strey.sandra@marshfieldclinic.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Caldwell, Physician
Organizational Affiliation
Marshfield Clinic Research Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Wave Molecular Diagnostics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Brower, PhD
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15284536
Citation
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.
Results Reference
background
PubMed Identifier
15596953
Citation
Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14.
Results Reference
background
PubMed Identifier
16303885
Citation
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.
Results Reference
background
PubMed Identifier
16160068
Citation
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.
Results Reference
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Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing

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