Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
- Conditions
- DVTAnti-coagulation TherapyAtrial FibrillationJoint Surgery MultiplePulmonary EmbolismProsthetic Replacement of Mitral Valve
- Interventions
- Device: Warfarin GenoSTAT Test
- Registration Number
- NCT01305148
- Lead Sponsor
- Iverson Genetic Diagnostics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 3800
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Registry Warfarin GenoSTAT Test 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 Randomized - Genetic Warfarin GenoSTAT Test 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
- Primary Outcome Measures
Name Time Method Incidence of warfarin related clinical events 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.
- Secondary Outcome Measures
Name Time Method Minor hemorrhagic events 90 days The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
Prescriber adherence 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
Warfarin Doses 90 days Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Hemorrhagic Events 90 days The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
INR tests 30 days The percentage of the total INR tests performed in the first 30 days which are out of target range
SF-12 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
INR Tests 30 days Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Major thromboembolic events 90 days The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
Trial Locations
- Locations (56)
St. Alphonsus Regional Medical Center
🇺🇸Boise, Idaho, United States
Billings Clinic
🇺🇸Billings, Montana, United States
Medical Consultants, PC
🇺🇸Muncie, Indiana, United States
Infinity-Northshore
🇺🇸Fort Lauderdale, Florida, United States
Carle Foundation
🇺🇸Urbana, Illinois, United States
Orthoarkansas
🇺🇸Little Rock, Arkansas, United States
Rockford Cardiovascular Research Foundation
🇺🇸Rockford, Illinois, United States
Cardiology of Atlanta
🇺🇸Atlanta, Georgia, United States
Atlanta Heart Group
🇺🇸Decatur, Georgia, United States
Thoracic and Cardiovascular Institute
🇺🇸Lansing, Michigan, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Cardiovascular Consultants - Thunderbird
🇺🇸Glendale, Arizona, United States
St. Mary's
🇺🇸Evansville, Indiana, United States
Hackensack Medical Center
🇺🇸Hackensack, New Jersey, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
Aultman Hospital
🇺🇸Canton, Ohio, United States
NECCR
🇺🇸Falls River, Massachusetts, United States
Central Bucks Cardiology
🇺🇸Doylestown, Pennsylvania, United States
Grady Hospital
🇺🇸Atlanta, Georgia, United States
Palmetto Health Richland
🇺🇸Columbia, South Carolina, United States
Nebraska Heart
🇺🇸Lincoln, Nebraska, United States
New Mexico Heart Institute
🇺🇸Albuquerque, New Mexico, United States
Sanford Health Research
🇺🇸Fargo, North Dakota, United States
Carolina Cardiology
🇺🇸Rock Hill, South Carolina, United States
Polyclinic
🇺🇸Seattle, Washington, United States
Providence Health Network
🇺🇸Waco, Texas, United States
Corvallis Clinic
🇺🇸Corvallis, Oregon, United States
Marshfield Clinic Research Foundation
🇺🇸Marshfield, Wisconsin, United States
Legacy Heart Center
🇺🇸Plano, Texas, United States
Overlake Hospital
🇺🇸Bellevue, Washington, United States
Franciscan Research Center
🇺🇸Tacoma, Washington, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Veterans' Affairs Medical Center
🇺🇸Birmingham, Alabama, United States
Colorado Heart & Vascular
🇺🇸Denver, Colorado, United States
St. Thomas Research Institute
🇺🇸Nashville, Tennessee, United States
Nexxus Research
🇺🇸Bedford, Texas, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Cardiovascular Consultants - Phoenix
🇺🇸Phoenix, Arizona, United States
Comprehensive Cardiovascular Specialists
🇺🇸Alhambra, California, United States
Okaloosa Heart & Vascular
🇺🇸Crestview, Florida, United States
Southern Heart Research Institute
🇺🇸Riverdale, Georgia, United States
Nebraska Heart Institute
🇺🇸Grand Island, Nebraska, United States
Alegent
🇺🇸Omaha, Nebraska, United States
Intermountain Medical Center
🇺🇸Murray, Utah, United States
Family Health Care of Ellensburg
🇺🇸Ellensburg, Washington, United States
Swedish Hospital
🇺🇸Seattle, Washington, United States
St. Joseph's Medical Center
🇺🇸Stockton, California, United States
Infinity Clinical Research
🇺🇸Hollywood, Florida, United States
Heart Rhythm Specialists
🇺🇸Naples, Florida, United States
Community Hospital Anderson
🇺🇸Anderson, Indiana, United States
Cox Medical Center
🇺🇸Springfield, Missouri, United States
Bend Memorial Clinic
🇺🇸Bend, Oregon, United States
Scott & White
🇺🇸Temple, Texas, United States
Kansas City Heart Foundation
🇺🇸Kansas City, Missouri, United States
Texas Cardiac Arrhythmia
🇺🇸Austin, Texas, United States