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

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ClinicalTrials.gov Identifier: NCT00484640
Recruitment Status : Unknown
Verified June 2007 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was:  Not yet recruiting
First Posted : June 11, 2007
Last Update Posted : June 11, 2007
Sponsor:
Collaborator:
Marshfield Clinic Research Foundation
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)

June 4, 2007
June 11, 2007
June 11, 2007
June 2007
Not Provided
  • weighted time in therapeutic range
  • absolute deviation from clinically optimal dose
Same as current
No Changes Posted
  • time to stable dose in therapeutic target range
  • warfarin related adverse drug events
  • time to first INR above 4
Same as current
Not Provided
Not Provided
 
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
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.
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
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Deep Venous Thrombosis
  • Heart Valve Replacement
  • Pulmonary Embolism
Drug: Coumadin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
260
Same as current
May 2008
Not Provided

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00484640
R01HS016335-01( U.S. AHRQ Grant/Contract )
Yes
Not Provided
Not Provided
Not Provided
Agency for Healthcare Research and Quality (AHRQ)
Marshfield Clinic Research Foundation
Principal Investigator: Michael Caldwell, Physician Marshfield Clinic Research Foundation
Agency for Healthcare Research and Quality (AHRQ)
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP