- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00484640
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing
June 8, 2007 updated by: Agency for Healthcare Research and Quality (AHRQ)
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
260
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Deborah J Hilgemann, Res. Coord.
- Phone Number: same 715-389-3774
- Email: hilgemann.deborah@marshfieldclinic.org
Study Contact Backup
- Name: Sandra K Strey, Res. Coord.
- Phone Number: same 715-389-4030
- Email: strey.sandra@marshfieldclinic.org
Study Locations
-
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Wisconsin
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Madison, Wisconsin, United States, 53719
- Third Wave Molecular Diagnostics
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Sub-Investigator:
- Amy Brower, PhD
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
weighted time in therapeutic range
|
absolute deviation from clinically optimal dose
|
Secondary Outcome Measures
Outcome Measure |
---|
time to stable dose in therapeutic target range
|
warfarin related adverse drug events
|
time to first INR above 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Michael Caldwell, Physician, Marshfield Clinic Research Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Study Completion (Anticipated)
May 1, 2008
Study Registration Dates
First Submitted
June 4, 2007
First Submitted That Met QC Criteria
June 8, 2007
First Posted (Estimate)
June 11, 2007
Study Record Updates
Last Update Posted (Estimate)
June 11, 2007
Last Update Submitted That Met QC Criteria
June 8, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01HS016335-01 (U.S. AHRQ Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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