Atrial Fibrillation Clinical Trial
— WARFARINOfficial title:
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
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.
Status | Suspended |
Enrollment | 3800 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | New Mexico Heart Institute | Albuquerque | New Mexico |
United States | Comprehensive Cardiovascular Specialists | Alhambra | California |
United States | Community Hospital Anderson | Anderson | Indiana |
United States | Mission Hospital | Asheville | North Carolina |
United States | Cardiology of Atlanta | Atlanta | Georgia |
United States | Grady Hospital | Atlanta | Georgia |
United States | Texas Cardiac Arrhythmia | Austin | Texas |
United States | Nexxus Research | Bedford | Texas |
United States | Overlake Hospital | Bellevue | Washington |
United States | Bend Memorial Clinic | Bend | Oregon |
United States | Billings Clinic | Billings | Montana |
United States | Veterans' Affairs Medical Center | Birmingham | Alabama |
United States | St. Alphonsus Regional Medical Center | Boise | Idaho |
United States | Aultman Hospital | Canton | Ohio |
United States | Rush University Medical Center | Chicago | Illinois |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Palmetto Health Richland | Columbia | South Carolina |
United States | Corvallis Clinic | Corvallis | Oregon |
United States | Okaloosa Heart & Vascular | Crestview | Florida |
United States | Atlanta Heart Group | Decatur | Georgia |
United States | Colorado Heart & Vascular | Denver | Colorado |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Central Bucks Cardiology | Doylestown | Pennsylvania |
United States | Family Health Care of Ellensburg | Ellensburg | Washington |
United States | St. Mary's | Evansville | Indiana |
United States | NECCR | Falls River | Massachusetts |
United States | Sanford Health Research | Fargo | North Dakota |
United States | Infinity-Northshore | Fort Lauderdale | Florida |
United States | Cardiovascular Consultants - Thunderbird | Glendale | Arizona |
United States | Nebraska Heart Institute | Grand Island | Nebraska |
United States | Hackensack Medical Center | Hackensack | New Jersey |
United States | Infinity Clinical Research | Hollywood | Florida |
United States | Kansas City Heart Foundation | Kansas City | Missouri |
United States | Thoracic and Cardiovascular Institute | Lansing | Michigan |
United States | Nebraska Heart | Lincoln | Nebraska |
United States | Orthoarkansas | Little Rock | Arkansas |
United States | Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | Medical Consultants, PC | Muncie | Indiana |
United States | Intermountain Medical Center | Murray | Utah |
United States | Heart Rhythm Specialists | Naples | Florida |
United States | St. Thomas Research Institute | Nashville | Tennessee |
United States | Alegent | Omaha | Nebraska |
United States | Cardiovascular Consultants - Phoenix | Phoenix | Arizona |
United States | Legacy Heart Center | Plano | Texas |
United States | Southern Heart Research Institute | Riverdale | Georgia |
United States | Carolina Cardiology | Rock Hill | South Carolina |
United States | Rockford Cardiovascular Research Foundation | Rockford | Illinois |
United States | Sarasota Memorial Hospital | Sarasota | Florida |
United States | Polyclinic | Seattle | Washington |
United States | Swedish Hospital | Seattle | Washington |
United States | Cox Medical Center | Springfield | Missouri |
United States | St. Joseph's Medical Center | Stockton | California |
United States | Franciscan Research Center | Tacoma | Washington |
United States | Scott & White | Temple | Texas |
United States | Carle Foundation | Urbana | Illinois |
United States | Providence Health Network | Waco | Texas |
Lead Sponsor | Collaborator |
---|---|
Iverson Genetic Diagnostics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | INR Tests | Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range) | 30 days | Yes |
Secondary | Warfarin Doses | Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range) | 90 days | No |
Secondary | Hemorrhagic Events | The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation | 90 days | Yes |
Secondary | Minor hemorrhagic events | The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation | 90 days | Yes |
Secondary | Major thromboembolic events | The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for | 90 days | Yes |
Secondary | INR tests | The percentage of the total INR tests performed in the first 30 days which are out of target range | 30 days | No |
Secondary | SF-12 | 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 | No |
Secondary | Prescriber adherence | 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 | No |
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