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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Agency for Healthcare Research and Quality (AHRQ).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Marshfield Clinic Research Foundation
Information provided by:
Agency for Healthcare Research and Quality (AHRQ)
ClinicalTrials.gov Identifier:
NCT00484640
First received: June 4, 2007
Last updated: June 8, 2007
Last verified: June 2007
  Purpose

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 Intervention
Atrial Fibrillation
Deep Venous Thrombosis
Heart Valve Replacement
Pulmonary Embolism
Drug: Coumadin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing

Resource links provided by NLM:


Further study details as provided by Agency for Healthcare Research and Quality (AHRQ):

Primary Outcome Measures:
  • weighted time in therapeutic range
  • absolute deviation from clinically optimal dose

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

Estimated Enrollment: 260
Study Start Date: June 2007
Estimated Study Completion Date: May 2008
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484640

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
United States, Wisconsin
Third Wave Molecular Diagnostics Not yet recruiting
Madison, Wisconsin, United States, 53719
Sub-Investigator: Amy Brower, PhD         
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Marshfield Clinic Research Foundation
Investigators
Principal Investigator: Michael Caldwell, Physician Marshfield Clinic Research Foundation
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00484640     History of Changes
Other Study ID Numbers: #RO1 HS 016335-01
Study First Received: June 4, 2007
Last Updated: June 8, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Atrial Fibrillation
Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Pathologic Processes
Embolism and Thrombosis
Thromboembolism
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014