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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00484640
• Other study ID #: R01HS016335-01
• Status: Unknown status
• Phase: N/A
• First received: June 4, 2007
• Last updated: June 8, 2007
• Start date: June 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2007
• Source: Agency for Healthcare Research and Quality (AHRQ)
• Contact: Deborah J Hilgemann, Res. Coord.
• Phone: 715-389-3774
• Email: hilgemann.deborah[@]marshfieldclinic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 260
• Est. completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Coumadin

Locations

Country	Name	City	State
United States	Third Wave Molecular Diagnostics	Madison	Wisconsin
United States	Marshfield Clinic	Marshfield	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Agency for Healthcare Research and Quality (AHRQ)	Marshfield Clinic Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Greenlee RT, Vidaillet H. Recent progress in the epidemiology of atrial fibrillation. Curr Opin Cardiol. 2005 Jan;20(1):7-14. Review. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weighted time in therapeutic range
Primary	absolute deviation from clinically optimal dose
Secondary	time to stable dose in therapeutic target range
Secondary	warfarin related adverse drug events
Secondary	time to first INR above 4