- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01305148
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN) (WARFARIN)
August 27, 2015 updated by: Iverson Genetic Diagnostics, Inc.
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.
Study Overview
Status
Suspended
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
3800
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Veterans' Affairs Medical Center
-
-
Arizona
-
Glendale, Arizona, United States, 85306
- Cardiovascular Consultants - Thunderbird
-
Phoenix, Arizona, United States, 85015
- Cardiovascular Consultants - Phoenix
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Orthoarkansas
-
-
California
-
Alhambra, California, United States, 91801
- Comprehensive Cardiovascular Specialists
-
Stockton, California, United States, 95204
- St. Joseph's Medical Center
-
-
Colorado
-
Denver, Colorado, United States, 80204
- Colorado Heart & Vascular
-
-
Florida
-
Crestview, Florida, United States, 32539
- Okaloosa Heart & Vascular
-
Fort Lauderdale, Florida, United States, 33313
- Infinity-Northshore
-
Hollywood, Florida, United States, 33021
- Infinity Clinical Research
-
Naples, Florida, United States, 34119
- Heart Rhythm Specialists
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
-
-
Georgia
-
Atlanta, Georgia, United States, 30303
- Grady Hospital
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Atlanta, Georgia, United States, 30328
- Cardiology of Atlanta
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Decatur, Georgia, United States, 30033
- Atlanta Heart Group
-
Riverdale, Georgia, United States, 30274
- Southern Heart Research Institute
-
-
Idaho
-
Boise, Idaho, United States, 83702
- St. Alphonsus Regional Medical Center
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Rush University Medical Center
-
Rockford, Illinois, United States, 61107
- Rockford Cardiovascular Research Foundation
-
Urbana, Illinois, United States, 61801
- Carle Foundation
-
-
Indiana
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Anderson, Indiana, United States, 46011
- Community Hospital Anderson
-
Evansville, Indiana, United States, 47750
- St. Mary's
-
Muncie, Indiana, United States, 47303
- Medical Consultants, Pc
-
-
Massachusetts
-
Falls River, Massachusetts, United States, 02720
- NECCR
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-
Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
Lansing, Michigan, United States, 48910
- Thoracic and Cardiovascular Institute
-
-
Missouri
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Kansas City, Missouri, United States, 64114
- Kansas City Heart Foundation
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Springfield, Missouri, United States, 65807
- Cox Medical Center
-
-
Montana
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Billings, Montana, United States, 59101
- Billings Clinic
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-
Nebraska
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Grand Island, Nebraska, United States, 68803
- Nebraska Heart Institute
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Lincoln, Nebraska, United States, 68526
- Nebraska Heart
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Omaha, Nebraska, United States, 68124
- Alegent
-
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack Medical Center
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New Mexico
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Albuquerque, New Mexico, United States, 87102
- New Mexico Heart Institute
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-
North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital
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North Dakota
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Fargo, North Dakota, United States, 58122
- Sanford Health Research
-
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Ohio
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Canton, Ohio, United States, 44708
- Aultman Hospital
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Cincinnati, Ohio, United States, 45219
- The Christ Hospital
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Oregon
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Bend, Oregon, United States, 97701
- Bend Memorial Clinic
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Corvallis, Oregon, United States, 97330
- Corvallis Clinic
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Pennsylvania
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Doylestown, Pennsylvania, United States, 18901
- Central Bucks Cardiology
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South Carolina
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Columbia, South Carolina, United States, 29203
- Palmetto Health Richland
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Rock Hill, South Carolina, United States, 29732
- Carolina Cardiology
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Tennessee
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Nashville, Tennessee, United States, 37205
- St. Thomas Research Institute
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Texas
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Austin, Texas, United States, 78705
- Texas Cardiac Arrhythmia
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Bedford, Texas, United States, 76021
- Nexxus Research
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Plano, Texas, United States, 75024
- Legacy Heart Center
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Temple, Texas, United States, 76508
- Scott & White
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Waco, Texas, United States, 76712
- Providence Health Network
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Utah
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Murray, Utah, United States, 84157
- Intermountain Medical Center
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Washington
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Bellevue, Washington, United States, 98004
- Overlake Hospital
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Ellensburg, Washington, United States, 98926
- Family Health Care of Ellensburg
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Seattle, Washington, United States, 98104
- Polyclinic
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Seattle, Washington, United States, 98122
- Swedish Hospital
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Tacoma, Washington, United States, 98405
- Franciscan Research Center
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Wisconsin
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Marshfield, Wisconsin, United States, 54449
- Marshfield Clinic Research Foundation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women at least 65 years old
- 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:
- Unable to complete the study materials (questionnaires) with or without assistance (for example, those with dementia)
- A previous genetically determined warfarin dose
- The treating physician does not agree to use the recommended warfarin dose or feels that the patient should not be enrolled in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Other Names:
|
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
|
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of warfarin related clinical events
Time Frame: 30 days
|
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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
INR Tests
Time Frame: 30 days
|
Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
|
30 days
|
Warfarin Doses
Time Frame: 90 days
|
Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
|
90 days
|
Hemorrhagic Events
Time Frame: 90 days
|
The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
|
90 days
|
Minor hemorrhagic events
Time Frame: 90 days
|
The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
|
90 days
|
Major thromboembolic events
Time Frame: 90 days
|
The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
|
90 days
|
INR tests
Time Frame: 30 days
|
The percentage of the total INR tests performed in the first 30 days which are out of target range
|
30 days
|
SF-12
Time Frame: 90 days
|
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
|
90 days
|
Prescriber adherence
Time Frame: 30 days
|
Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: An Pang Chieng, MD, Alhambra Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
December 1, 2015
Study Completion (Anticipated)
December 1, 2015
Study Registration Dates
First Submitted
February 25, 2011
First Submitted That Met QC Criteria
February 25, 2011
First Posted (Estimate)
February 28, 2011
Study Record Updates
Last Update Posted (Estimate)
August 31, 2015
Last Update Submitted That Met QC Criteria
August 27, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IG-0109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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