Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN) (WARFARIN)

This study has suspended participant recruitment.
(Sponsor is raising funds for the remainder of the study)
Sponsor:
Information provided by (Responsible Party):
Iverson Genetic Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01305148
First received: February 25, 2011
Last updated: August 27, 2015
Last verified: August 2015
  Purpose
The WARFARIN Study is a clinical trial designed to determine if the use of genetic information related to warfarin sensitivity can help create a dose of warfarin that will result in less hospitalizations and deaths related to warfarin.

Condition Intervention
Anti-coagulation Therapy
DVT
Pulmonary Embolism
Joint Surgery Multiple
Atrial Fibrillation
Prosthetic Replacement of Mitral Valve
Device: Warfarin GenoSTAT Test

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

Resource links provided by NLM:


Further study details as provided by Iverson Genetic Diagnostics, Inc.:

Primary Outcome Measures:
  • Incidence of warfarin related clinical events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    To determine if using warfarin-related pharmacogenetic information in calculating warfarin doses will change the incidence of warfarin-related clinical events, including major hemorrhage and thromboembolic events, at 30 days after initial dose, when compared to warfarin doses calculated without pharmacogenetic data.


Secondary Outcome Measures:
  • INR Tests [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)

  • Warfarin Doses [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)

  • Hemorrhagic Events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation

  • Minor hemorrhagic events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation

  • Major thromboembolic events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for

  • INR tests [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    The percentage of the total INR tests performed in the first 30 days which are out of target range

  • SF-12 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The overall, Physical Composite Score (PCS) and Mental Composite Score (MCS) of the SF-12 quality of life questionnaire at 30 days and at 90 days separately after warfarin initiation

  • Prescriber adherence [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin


Estimated Enrollment: 3800
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Randomized - Genetic
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
Device: Warfarin GenoSTAT Test
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Other Names:
  • Warfarin GenoSTAT
  • pharmacogenetic testing
  • personalized medicine
No Intervention: Randomized - Clinical
Subjects who are randomized to 90 days of follow-up and whose warfarin dose was determined using the genetic information from clinical information alone through the warfarindosing.org website
Experimental: Registry
Subjects who are followed 30 days of follow-up and whose warfarin dose was determined using the genetic information from the GenoSTAT test and clinical information through the warfarindosing.org website
Device: Warfarin GenoSTAT Test
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Other Names:
  • Warfarin GenoSTAT
  • pharmacogenetic testing
  • personalized medicine

  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women at least 65 years old
  2. Beginning warfarin (0 - 3 doses of warfarin taken at the time of enrollment) for a variety of diseases or conditions that require at least 30 days oral anticoagulation with target INR ≥ 2.0

Exclusion Criteria:

  1. Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
  2. A previous genetically determined warfarin dose
  3. The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
  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: NCT01305148

  Hide Study Locations
Locations
United States, Alabama
Veterans' Affairs Medical Center
Birmingham, Alabama, United States, 35233
United States, Arizona
Cardiovascular Consultants - Thunderbird
Glendale, Arizona, United States, 85306
Cardiovascular Consultants - Phoenix
Phoenix, Arizona, United States, 85015
United States, Arkansas
Orthoarkansas
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Cardiovascular Specialists
Alhambra, California, United States, 91801
St. Joseph's Medical Center
Stockton, California, United States, 95204
United States, Colorado
Colorado Heart & Vascular
Denver, Colorado, United States, 80204
United States, Florida
Okaloosa Heart & Vascular
Crestview, Florida, United States, 32539
Infinity-Northshore
Fort Lauderdale, Florida, United States, 33313
Infinity Clinical Research
Hollywood, Florida, United States, 33021
Heart Rhythm Specialists
Naples, Florida, United States, 34119
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Grady Hospital
Atlanta, Georgia, United States, 30303
Cardiology of Atlanta
Atlanta, Georgia, United States, 30328
Atlanta Heart Group
Decatur, Georgia, United States, 30033
Southern Heart Research Institute
Riverdale, Georgia, United States, 30274
United States, Idaho
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83702
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Rockford Cardiovascular Research Foundation
Rockford, Illinois, United States, 61107
Carle Foundation
Urbana, Illinois, United States, 61801
United States, Indiana
Community Hospital Anderson
Anderson, Indiana, United States, 46011
St. Mary's
Evansville, Indiana, United States, 47750
Medical Consultants, PC
Muncie, Indiana, United States, 47303
United States, Massachusetts
NECCR
Falls River, Massachusetts, United States, 02720
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Thoracic and Cardiovascular Institute
Lansing, Michigan, United States, 48910
United States, Missouri
Kansas City Heart Foundation
Kansas City, Missouri, United States, 64114
Cox Medical Center
Springfield, Missouri, United States, 65807
United States, Montana
Billings Clinic
Billings, Montana, United States, 59101
United States, Nebraska
Nebraska Heart Institute
Grand Island, Nebraska, United States, 68803
Nebraska Heart
Lincoln, Nebraska, United States, 68526
Alegent
Omaha, Nebraska, United States, 68124
United States, New Jersey
Hackensack Medical Center
Hackensack, New Jersey, United States, 07601
United States, New Mexico
New Mexico Heart Institute
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Mission Hospital
Asheville, North Carolina, United States, 28801
United States, North Dakota
Sanford Health Research
Fargo, North Dakota, United States, 58122
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44708
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Oregon
Bend Memorial Clinic
Bend, Oregon, United States, 97701
Corvallis Clinic
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
Central Bucks Cardiology
Doylestown, Pennsylvania, United States, 18901
United States, South Carolina
Palmetto Health Richland
Columbia, South Carolina, United States, 29203
Carolina Cardiology
Rock Hill, South Carolina, United States, 29732
United States, Tennessee
St. Thomas Research Institute
Nashville, Tennessee, United States, 37205
United States, Texas
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705
Nexxus Research
Bedford, Texas, United States, 76021
Legacy Heart Center
Plano, Texas, United States, 75024
Scott & White
Temple, Texas, United States, 76508
Providence Health Network
Waco, Texas, United States, 76712
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
United States, Washington
Overlake Hospital
Bellevue, Washington, United States, 98004
Family Health Care of Ellensburg
Ellensburg, Washington, United States, 98926
Polyclinic
Seattle, Washington, United States, 98104
Swedish Hospital
Seattle, Washington, United States, 98122
Franciscan Research Center
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Iverson Genetic Diagnostics, Inc.
Investigators
Principal Investigator: An Pang Chieng, MD Alhambra Hospital
  More Information

Additional Information:
Responsible Party: Iverson Genetic Diagnostics, Inc.
ClinicalTrials.gov Identifier: NCT01305148     History of Changes
Other Study ID Numbers: IG-0109 
Study First Received: February 25, 2011
Last Updated: August 27, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Iverson Genetic Diagnostics, Inc.:
warfarin
genetic testing
personalized medicine
anti-coagulants
coumadin

Additional relevant MeSH terms:
Atrial Fibrillation
Embolism
Pulmonary Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Warfarin
Anticoagulants

ClinicalTrials.gov processed this record on July 28, 2016