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Sponsor is raising funds for the remainder of the study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomized - Genetic | Experimental | 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 |
|
| Randomized - Clinical | No Intervention | 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 | |
| Registry | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Warfarin GenoSTAT Test | Device | Use of genetic information from the GenoSTAT test to determine the warfarin dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Warfarin Doses | Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An Pang Chieng, MD | Alhambra Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans' Affairs Medical Center | Birmingham | Alabama | 35233 | United States | ||
| Cardiovascular Consultants - Thunderbird |
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| 90 days |
| Hemorrhagic Events | The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation | 90 days |
| Minor hemorrhagic events | The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation | 90 days |
| Major thromboembolic events | The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for | 90 days |
| INR tests | The percentage of the total INR tests performed in the first 30 days which are out of target range | 30 days |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D011655 | Pulmonary Embolism |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| D057285 | Precision Medicine |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D013812 | Therapeutics |
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