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

NCT ID: NCT00484640

Last Updated: 2007-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-05-31

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Coumadin

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marshfield Clinic Research Foundation

OTHER

Sponsor Role: collaborator

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: lead

Principal Investigators

Michael Caldwell, Physician

Role: PRINCIPAL_INVESTIGATOR

Marshfield Clinic Research Foundation

Locations

Third Wave Molecular Diagnostics

Madison, Wisconsin, United States

Marshfield Clinic

Marshfield, Wisconsin, United States

Countries

United States

Central Contacts

Deborah J Hilgemann, Res. Coord.

Role: CONTACT

hilgemann.deborah@marshfieldclinic.org

715-389-3774 ext. same

Sandra K Strey, Res. Coord.

Role: CONTACT

strey.sandra@marshfieldclinic.org

715-389-4030 ext. same

References

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.

Reference Type: BACKGROUND

PMID: 15284536 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 15596953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16303885 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16160068 (View on PubMed)

Other Identifiers

R01HS016335-01

Identifier Type: AHRQ

Identifier Source: org_study_id

View Link