Study Stopped
Sponsor is raising funds for the remainder of the study
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
WARFARIN
1 other identifier
interventional
3,800
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Longer than P75 for not_applicable
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2011
CompletedFirst Posted
Study publicly available on registry
February 28, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 31, 2015
August 1, 2015
4.3 years
February 25, 2011
August 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of warfarin related clinical events
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 Outcomes (8)
INR Tests
30 days
Warfarin Doses
90 days
Hemorrhagic Events
90 days
Minor hemorrhagic events
90 days
Major thromboembolic events
90 days
- +3 more secondary outcomes
Study Arms (3)
Randomized - Genetic
EXPERIMENTALSubjects 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
Randomized - Clinical
NO INTERVENTIONSubjects 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
Registry
EXPERIMENTALSubjects 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
Interventions
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Veterans' Affairs Medical Center
Birmingham, Alabama, 35233, United States
Cardiovascular Consultants - Thunderbird
Glendale, Arizona, 85306, United States
Cardiovascular Consultants - Phoenix
Phoenix, Arizona, 85015, United States
Orthoarkansas
Little Rock, Arkansas, 72205, United States
Comprehensive Cardiovascular Specialists
Alhambra, California, 91801, United States
St. Joseph's Medical Center
Stockton, California, 95204, United States
Colorado Heart & Vascular
Denver, Colorado, 80204, United States
Okaloosa Heart & Vascular
Crestview, Florida, 32539, United States
Infinity-Northshore
Fort Lauderdale, Florida, 33313, United States
Infinity Clinical Research
Hollywood, Florida, 33021, United States
Heart Rhythm Specialists
Naples, Florida, 34119, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Grady Hospital
Atlanta, Georgia, 30303, United States
Cardiology of Atlanta
Atlanta, Georgia, 30328, United States
Atlanta Heart Group
Decatur, Georgia, 30033, United States
Southern Heart Research Institute
Riverdale, Georgia, 30274, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, 83702, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Rockford Cardiovascular Research Foundation
Rockford, Illinois, 61107, United States
Carle Foundation
Urbana, Illinois, 61801, United States
Community Hospital Anderson
Anderson, Indiana, 46011, United States
St. Mary's
Evansville, Indiana, 47750, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
NECCR
Falls River, Massachusetts, 02720, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Thoracic and Cardiovascular Institute
Lansing, Michigan, 48910, United States
Kansas City Heart Foundation
Kansas City, Missouri, 64114, United States
Cox Medical Center
Springfield, Missouri, 65807, United States
Billings Clinic
Billings, Montana, 59101, United States
Nebraska Heart Institute
Grand Island, Nebraska, 68803, United States
Nebraska Heart
Lincoln, Nebraska, 68526, United States
Alegent
Omaha, Nebraska, 68124, United States
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Sanford Health Research
Fargo, North Dakota, 58122, United States
Aultman Hospital
Canton, Ohio, 44708, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Bend Memorial Clinic
Bend, Oregon, 97701, United States
Corvallis Clinic
Corvallis, Oregon, 97330, United States
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901, United States
Palmetto Health Richland
Columbia, South Carolina, 29203, United States
Carolina Cardiology
Rock Hill, South Carolina, 29732, United States
St. Thomas Research Institute
Nashville, Tennessee, 37205, United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705, United States
Nexxus Research
Bedford, Texas, 76021, United States
Legacy Heart Center
Plano, Texas, 75024, United States
Scott & White
Temple, Texas, 76508, United States
Providence Health Network
Waco, Texas, 76712, United States
Intermountain Medical Center
Murray, Utah, 84157, United States
Overlake Hospital
Bellevue, Washington, 98004, United States
Family Health Care of Ellensburg
Ellensburg, Washington, 98926, United States
Polyclinic
Seattle, Washington, 98104, United States
Swedish Hospital
Seattle, Washington, 98122, United States
Franciscan Research Center
Tacoma, Washington, 98405, United States
Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
An Pang Chieng, MD
Alhambra Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2011
First Posted
February 28, 2011
Study Start
August 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
August 31, 2015
Record last verified: 2015-08