We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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)

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Deep Venous Thrombosis Heart Valve Replacement Pulmonary Embolism Drug: Coumadin Not Applicable

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
Study Start Date : June 2007
Estimated Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. weighted time in therapeutic range
  2. absolute deviation from clinically optimal dose

Secondary Outcome Measures :
  1. time to stable dose in therapeutic target range
  2. warfarin related adverse drug events
  3. time to first INR above 4

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00484640


Contacts
Layout table for location contacts
Contact: Deborah J Hilgemann, Res. Coord. 715-389-3774 ext same hilgemann.deborah@marshfieldclinic.org
Contact: Sandra K Strey, Res. Coord. 715-389-4030 ext same strey.sandra@marshfieldclinic.org

Locations
Layout table for location information
United States, Wisconsin
Third Wave Molecular Diagnostics
Madison, Wisconsin, United States, 53719
Sub-Investigator: Amy Brower, PhD         
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Agency for Healthcare Research and Quality (AHRQ)
Marshfield Clinic Research Foundation
Investigators
Layout table for investigator information
Principal Investigator: Michael Caldwell, Physician Marshfield Clinic Research Foundation
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00484640    
Other Study ID Numbers: R01HS016335-01 ( U.S. AHRQ Grant/Contract )
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: June 11, 2007
Last Verified: June 2007
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Embolism
Atrial Fibrillation
Thrombosis
Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants