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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Iverson Genetic Diagnostics, Inc.
Sponsor:
Information provided by (Responsible Party):
Iverson Genetic Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01305148
First received: February 25, 2011
Last updated: August 25, 2014
Last verified: August 2014
  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
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

Contacts
Contact: Dean Sproles dean@iversongenetics.com

  Hide Study Locations
Locations
United States, Alabama
Veterans' Affairs Medical Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Pamela Parker, MD    205-933-8101      
Principal Investigator: Pamela Parker, MD         
United States, Arizona
Cardiovascular Consultants - Thunderbird Terminated
Glendale, Arizona, United States, 85306
Cardiovascular Consultants - Phoenix Terminated
Phoenix, Arizona, United States, 85015
United States, Arkansas
Orthoarkansas Terminated
Little Rock, Arkansas, United States, 72205
United States, California
Comprehensive Cardiovascular Specialists Recruiting
Alhambra, California, United States, 91801
Contact: Debbie Lai, NP    626-281-8663      
Principal Investigator: Peter Fung, MD         
Palo Alto Medical Foundation Withdrawn
Palo Alto, California, United States, 94301
St. Joseph's Medical Center Recruiting
Stockton, California, United States, 95204
Contact: Teri Kozik, PhD    209-943-2000      
Principal Investigator: Teri Kozik, PhD         
United States, Colorado
Colorado Heart & Vascular Recruiting
Denver, Colorado, United States, 80204
Contact: Dana Long    303-522-3745      
Principal Investigator: Sameer Mehta, MD         
United States, Florida
Okaloosa Heart & Vascular Recruiting
Crestview, Florida, United States, 32539
Contact: Barbara Sierra    850-682-7212      
Principal Investigator: Juan Zarate, MD         
Infinity-Northshore Recruiting
Fort Lauderdale, Florida, United States, 33313
Contact: Alex Saenz    786-552-2180      
Principal Investigator: Alam Schwartz, MD         
Infinity Clinical Research Recruiting
Hollywood, Florida, United States, 33021
Contact: Rebecca Nemhard    945-965-4900      
Principal Investigator: Ann Robblee, PAC         
Heart Rhythm Specialists Recruiting
Naples, Florida, United States, 34119
Contact: Carlos Davison, MD    239-348-4290      
Principal Investigator: Carlos Davison, MD         
Sarasota Memorial Hospital Recruiting
Sarasota, Florida, United States, 34239
Contact: Amanda Miller, RN    941-917-6164      
Principal Investigator: Kirk Voelker, MD         
United States, Georgia
Cardiology of Atlanta Recruiting
Atlanta, Georgia, United States, 30328
Contact: Pat Rudolph    404-252-7970      
Principal Investigator: Hector Malave, MD         
Grady Hospital Terminated
Atlanta, Georgia, United States, 30303
Atlanta Heart Group Terminated
Decatur, Georgia, United States, 30033
Southern Heart Research Institute Terminated
Riverdale, Georgia, United States, 30274
United States, Idaho
St. Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83702
Contact: Nichole Whitener    208-367-2121      
Principal Investigator: Antonio Lopez, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Sherri Velez    312-942-3696      
Principal Investigator: Gezer, MD         
Rockford Cardiovascular Research Foundation Recruiting
Rockford, Illinois, United States, 61107
Contact: Joanne Carner    815-847-5835      
Principal Investigator: Farhod Farokhi, MD         
Carle Foundation Recruiting
Urbana, Illinois, United States, 61801
Contact: Tiffany McGeehon    217-337-2000      
Principal Investigator: Sanjay Mehta, MD         
United States, Indiana
Community Hospital Anderson Recruiting
Anderson, Indiana, United States, 46011
Contact: Brandie Preston       brandie.preston@ecommunity.com   
Principal Investigator: Preetham Jetty, MD         
St. Mary's Terminated
Evansville, Indiana, United States, 47750
Medical Consultants, PC Recruiting
Muncie, Indiana, United States, 47303
Contact: Haley Morgan    765-281-2166      
Principal Investigator: Jennifer Bow, NP         
United States, Massachusetts
NECCR Recruiting
Falls River, Massachusetts, United States, 02720
Contact: Jacqueline Difazio    508-672-7450      
Principal Investigator: Wajid Baig, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Susan Maddox, RN       SMADDOX1@hfhs.org   
Principal Investigator: Vinay Shah, MD         
Thoracic and Cardiovascular Institute Terminated
Lansing, Michigan, United States, 48910
United States, Missouri
Kansas City Heart Foundation Recruiting
Kansas City, Missouri, United States, 64114
Contact: Barb Lee       barb.lee@kchf.org   
Principal Investigator: John Lee, MD         
Cox Medical Center Recruiting
Springfield, Missouri, United States, 65807
Contact: Kaitlin Gilbert    416-269-0598      
Principal Investigator: Steven Rowe         
United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Mary Lou Simmons    406-255-8494      
Principal Investigator: Larry Severa, MD         
United States, Nebraska
Nebraska Heart Institute Recruiting
Grand Island, Nebraska, United States, 68803
Contact: Dawn Carpenter    800-644-3627      
Principal Investigator: Douglas Kosmicki, MD         
Nebraska Heart Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Corey Godfrey    402-328-3928      
Principal Investigator: Dennis Kosmicki, MD         
Alegent Recruiting
Omaha, Nebraska, United States, 68124
Contact: Jacque Taylor    402-343-8515      
Principal Investigator: Himanshu Agarwal, MD         
United States, New Jersey
Hackensack Medical Center Terminated
Hackensack, New Jersey, United States, 07601
United States, New Mexico
New Mexico Heart Institute Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Jill Atkins    505-843-2813      
Principal Investigator: Ross Downey, MD         
United States, North Carolina
Mission Hospital Recruiting
Asheville, North Carolina, United States, 28801
Contact: Leslie Shell, RN    828-213-7993      
Principal Investigator: Scott Joslin, MD         
United States, North Dakota
Sanford Health Research Recruiting
Fargo, North Dakota, United States, 58122
Contact: Amber Leach    701-234-5899      
Principal Investigator: Susan Farkas, MD         
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44708
Contact: Rachel Senter    330-489-9053      
Principal Investigator: Ira Friedlander, MD         
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Gina Knecht       Gina.Knecht@thechristhospital.com   
Principal Investigator: Philip Leming, MD         
United States, Oregon
Bend Memorial Clinic Terminated
Bend, Oregon, United States, 97701
Corvallis Clinic Terminated
Corvallis, Oregon, United States, 97330
United States, Pennsylvania
University Orthopedics Center Withdrawn
Altoona, Pennsylvania, United States, 16602
Central Bucks Cardiology Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Donna Taylor    215-345-1900 ext 300      
Principal Investigator: Michael Mooradd, MD         
United States, South Carolina
Palmetto Health Richland Recruiting
Columbia, South Carolina, United States, 29203
Contact: Georgia Welnick    803-434-7000      
Principal Investigator: Solomon Chesoni, MD         
Carolina Cardiology Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Beth Martinotti    803-324-5135      
Principal Investigator: Talal Baki, MD         
United States, Tennessee
St. Thomas Research Institute Terminated
Nashville, Tennessee, United States, 37205
United States, Texas
Texas Cardiac Arrhythmia Recruiting
Austin, Texas, United States, 78705
Contact: Kathryn Morgan    512-807-3150      
Principal Investigator: Javier Sanchez, MD         
Odyssey Research Withdrawn
Bedford, Texas, United States, 76021
Nexxus Research Recruiting
Bedford, Texas, United States, 76021
Contact: Amy Culpepper    817-358-9806      
Principal Investigator: David Kaner, DO         
Legacy Heart Center Recruiting
Plano, Texas, United States, 75024
Contact: Tonya Goldston       tgoldston@legacyheartcenter.com   
Principal Investigator: Marcus McKenzie, MD         
Scott & White Terminated
Temple, Texas, United States, 76508
Providence Health Network Recruiting
Waco, Texas, United States, 76712
Contact: Samina Ali    254-399-5400      
Principal Investigator: Sherwin Attai, MD         
United States, Utah
Intermountain Medical Center Recruiting
Murray, Utah, United States, 84157
Contact: Valerie Aston, RN    801-507-4606      
Principal Investigator: Scott Woller, MD         
United States, Washington
Overlake Hospital Recruiting
Bellevue, Washington, United States, 98004
Contact: Tina Fortney    425-688-5000      
Principal Investigator: Kathleen Gibson, MD         
Family Health Care of Ellensburg Recruiting
Ellensburg, Washington, United States, 98926
Contact: Denise Michaud       dbowman@fhcoe.com   
Principal Investigator: Byron Haney, MD         
Swedish Hospital Terminated
Seattle, Washington, United States, 98122
Polyclinic Recruiting
Seattle, Washington, United States, 98104
Contact: Kenita Davis    206-320-6766      
Principal Investigator: Christopher Cannon, MD         
Franciscan Research Center Recruiting
Tacoma, Washington, United States, 98405
Contact: Lisa Lundgren    253-426-6914      
Principal Investigator: Tony Casanova, PharmD         
United States, Wisconsin
Marshfield Clinic Research Foundation Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Cindy Cloakley    715-387-5511      
Principal Investigator: James Burmester, PhD         
Sponsors and Collaborators
Iverson Genetic Diagnostics, Inc.
Investigators
Principal Investigator: An Pang Chieng, MD Alhambra Hospital
  More Information

Additional Information:
No publications provided

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 25, 2014
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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014