Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
This study is currently recruiting participants.
Verified May 2013 by Iverson Genetic Diagnostics, Inc.
Sponsor:
Iverson Genetic Diagnostics, Inc.
Information provided by (Responsible Party):
Iverson Genetic Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01305148
First received: February 25, 2011
Last updated: May 23, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Warfarin Therapy |
Device: Warfarin GenoSTAT Test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN) |
Resource links provided by NLM:
Further study details as provided by Iverson Genetic Diagnostics, Inc.:
Primary Outcome Measures:
- Incidence of warfarin related clinical events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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:
- INR Tests [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
- Warfarin Doses [ Time Frame: 90 days ] [ Designated as safety issue: No ]Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
- Hemorrhagic Events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
- Minor hemorrhagic events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
- Major thromboembolic events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
- INR tests [ Time Frame: 30 days ] [ Designated as safety issue: No ]The percentage of the total INR tests performed in the first 30 days which are out of target range
- SF-12 [ Time Frame: 90 days ] [ Designated as safety issue: No ]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
- Prescriber adherence [ Time Frame: 30 days ] [ Designated as safety issue: No ]Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin
| Estimated Enrollment: | 3800 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Device: Warfarin GenoSTAT Test
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
|
Device: Warfarin GenoSTAT Test
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Other Names:
|
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01305148
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Contacts
| Contact: Dean Sproles | dean@iversongenetics.com |
Hide Study LocationsLocations
| United States, Arizona | |
| Cardiovascular Consultants - Thunderbird | Recruiting |
| Glendale, Arizona, United States, 85306 | |
| Contact: Nadira Trncic 602-652-8761 | |
| Principal Investigator: Marc Kates, MD | |
| Cardiovascular Consultants - Phoenix | Recruiting |
| Phoenix, Arizona, United States, 85015 | |
| Contact: Brigit Iles 602-824-9510 | |
| Principal Investigator: Chris Geohas, MD | |
| United States, Arkansas | |
| Orthoarkansas | Active, not recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Comprehensive Cardiovascular Specialists | Recruiting |
| Alhambra, California, United States, 91801 | |
| Contact: Debbie Lai, NP 626-281-8663 | |
| Principal Investigator: Peter Fung, MD | |
| Palo Alto Medical Foundation | Withdrawn |
| Palo Alto, California, United States, 94301 | |
| St. Joseph's Medical Center | Recruiting |
| Stockton, California, United States, 95204 | |
| Contact: Teri Kozik, PhD 209-943-2000 | |
| Principal Investigator: Teri Kozik, PhD | |
| United States, Colorado | |
| Colorado Heart & Vascular | Recruiting |
| Denver, Colorado, United States, 80204 | |
| Contact: Dana Long 303-522-3745 | |
| Principal Investigator: Sameer Mehta, MD | |
| United States, Florida | |
| Okaloosa Heart & Vascular | Recruiting |
| Crestview, Florida, United States, 32539 | |
| Contact: Barbara Sierra 850-682-7212 | |
| Principal Investigator: Juan Zarate, MD | |
| Infinity-Northshore | Recruiting |
| Fort Lauderdale, Florida, United States, 33313 | |
| Contact: Alex Saenz 786-552-2180 | |
| Principal Investigator: Alam Schwartz, MD | |
| Infinity Clinical Research | Recruiting |
| Hollywood, Florida, United States, 33021 | |
| Contact: Rebecca Nemhard 945-965-4900 | |
| Principal Investigator: Ann Robblee, PAC | |
| Sarasota Memorial Hospital | Recruiting |
| Sarasota, Florida, United States, 34239 | |
| Contact: Amanda Miller, RN 941-917-6164 | |
| Principal Investigator: Kirk Voelker, MD | |
| United States, Georgia | |
| Grady Hospital | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Jo Ann Cross 404-616-4123 | |
| Principal Investigator: Adefisayo Oduwole, MD | |
| Cardiology of Atlanta | Recruiting |
| Atlanta, Georgia, United States, 30328 | |
| Contact: Pat Rudolph 404-252-7970 | |
| Principal Investigator: Hector Malave, MD | |
| Atlanta Heart Group | Terminated |
| Decatur, Georgia, United States, 30033 | |
| Atlanta Heart Group | Recruiting |
| Decatur, Georgia, United States, 30033 | |
| Contact: Joy Burnette 404-297-9077 | |
| Principal Investigator: Paul Kirschbaum, MD | |
| Southern Heart Research Institute | Recruiting |
| Riverdale, Georgia, United States, 30274 | |
| Contact: Jessica Waters 770-992-2100 | |
| Principal Investigator: Olatidoye, MD | |
| United States, Idaho | |
| St. Alphonsus Regional Medical Center | Recruiting |
| Boise, Idaho, United States, 83702 | |
| Contact: Nichole Whitener 208-367-2121 | |
| Principal Investigator: Antonio Lopez, MD | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Sherri Velez 312-942-3696 | |
| Principal Investigator: Gezer, MD | |
| Rockford Cardiovascular Research Foundation | Recruiting |
| Rockford, Illinois, United States, 61107 | |
| Contact: Joanne Carner 815-847-5835 | |
| Principal Investigator: Farhod Farokhi, MD | |
| Carle Foundation | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| Contact: Tiffany McGeehon 217-337-2000 | |
| Principal Investigator: Sanjay Mehta, MD | |
| United States, Indiana | |
| Community Hospital Anderson | Recruiting |
| Anderson, Indiana, United States, 46011 | |
| Contact: Brandie Preston brandie.preston@ecommunity.com | |
| Principal Investigator: Preetham Jetty, MD | |
| St. Mary's | Recruiting |
| Evansville, Indiana, United States, 47750 | |
| Contact: Karen Roper 812-485-7028 | |
| Principal Investigator: Asem Rimwai, MD | |
| United States, Massachusetts | |
| NECCR | Recruiting |
| Falls River, Massachusetts, United States, 02720 | |
| Contact: Jacqueline Difazio 508-672-7450 | |
| Principal Investigator: Wajid Baig, MD | |
| United States, Michigan | |
| Henry Ford Hospital | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Susan Maddox, RN SMADDOX1@hfhs.org | |
| Principal Investigator: Stanley Kaatz, MD | |
| Thoracic and Cardiovascular Institute | Recruiting |
| Lansing, Michigan, United States, 48910 | |
| Contact: Nancy Miller 517-483-8428 | |
| Principal Investigator: John Ip, MD | |
| United States, Missouri | |
| Kansas City Heart Foundation | Recruiting |
| Kansas City, Missouri, United States, 64114 | |
| Contact: Barb Lee barb.lee@kchf.org | |
| Principal Investigator: John Lee, MD | |
| Cox Medical Center | Recruiting |
| Springfield, Missouri, United States, 65807 | |
| Contact: Kaitlin Gilbert 416-269-0598 | |
| Principal Investigator: Steven Rowe | |
| United States, Montana | |
| Billings Clinic | Recruiting |
| Billings, Montana, United States, 59101 | |
| Contact: Mary Lou Simmons 406-255-8494 | |
| Principal Investigator: Larry Severa, MD | |
| United States, Nebraska | |
| Nebraska Heart Institute | Recruiting |
| Grand Island, Nebraska, United States, 68803 | |
| Contact: Dawn Carpenter 800-644-3627 | |
| Principal Investigator: Douglas Kosmicki, MD | |
| Nebraska Heart | Recruiting |
| Lincoln, Nebraska, United States, 68526 | |
| Contact: Corey Godfrey 402-328-3928 | |
| Principal Investigator: Dennis Kosmicki, MD | |
| Alegent | Recruiting |
| Omaha, Nebraska, United States, 68124 | |
| Contact: Jacque Taylor 402-343-8515 | |
| Principal Investigator: Himanshu Agarwal, MD | |
| United States, New Jersey | |
| Hackensack Medical Center | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| Contact: Diane Agar 201-336-8311 | |
| Principal Investigator: Yaron Bareket, MD | |
| United States, New Mexico | |
| New Mexico Heart Institute | Recruiting |
| Albuquerque, New Mexico, United States, 87102 | |
| Contact: Jill Atkins 505-843-2813 | |
| Principal Investigator: Ross Downey, MD | |
| United States, North Carolina | |
| Mission Hospital | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Leslie Shell, RN 828-213-7993 | |
| Principal Investigator: Scott Joslin, MD | |
| United States, Ohio | |
| Aultman Hospital | Recruiting |
| Canton, Ohio, United States, 44708 | |
| Contact: Rachel Senter 330-489-9053 | |
| Principal Investigator: Ira Friedlander, MD | |
| The Christ Hospital | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Gina Knecht Gina.Knecht@thechristhospital.com | |
| Principal Investigator: Philip Leming, MD | |
| United States, Oregon | |
| Bend Memorial Clinic | Recruiting |
| Bend, Oregon, United States, 97701 | |
| Contact: Anne Bergin abergin@bmctotalcare.com | |
| Principal Investigator: John Lasala, MD | |
| Corvallis Clinic | Recruiting |
| Corvallis, Oregon, United States, 97330 | |
| Contact: Sheena Strohmayer 541-754-1398 | |
| Principal Investigator: Michael Chen, MD | |
| United States, Pennsylvania | |
| Central Bucks Cardiology | Recruiting |
| Doylestown, Pennsylvania, United States, 18901 | |
| Contact: Donna Taylor 215-345-1900 ext 300 | |
| Principal Investigator: Michael Mooradd, MD | |
| United States, South Carolina | |
| Palmetto Health Richland | Recruiting |
| Columbia, South Carolina, United States, 29203 | |
| Contact: Georgia Welnick 803-434-7000 | |
| Principal Investigator: Solomon Chesoni, MD | |
| Carolina Cardiology | Recruiting |
| Rock Hill, South Carolina, United States, 29732 | |
| Contact: Beth Martinotti 803-324-5135 | |
| Principal Investigator: Talal Baki, MD | |
| United States, Tennessee | |
| St. Thomas Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37205 | |
| Contact: Lynn Peterson 615-222-5394 | |
| Principal Investigator: James Baker, MD | |
| United States, Texas | |
| Odyssey Research | Withdrawn |
| Bedford, Texas, United States, 76021 | |
| Nexxus Research | Recruiting |
| Bedford, Texas, United States, 76021 | |
| Contact: Amy Culpepper 817-358-9806 | |
| Principal Investigator: David Kaner, DO | |
| Legacy Heart Center | Recruiting |
| Plano, Texas, United States, 75024 | |
| Contact: Tonya Goldston tgoldston@legacyheartcenter.com | |
| Principal Investigator: Marcus McKenzie, MD | |
| Scott & White | Active, not recruiting |
| Temple, Texas, United States, 76508 | |
| Providence Health Network | Recruiting |
| Waco, Texas, United States, 76712 | |
| Contact: Samina Ali 254-399-5400 | |
| Principal Investigator: Sherwin Attai, MD | |
| United States, Utah | |
| Intermountain Medical Center | Recruiting |
| Murray, Utah, United States, 84157 | |
| Contact: Valerie Aston, RN 801-507-4606 | |
| Principal Investigator: Scott Woller, MD | |
| United States, Washington | |
| Overlake Hospital | Recruiting |
| Bellevue, Washington, United States, 98004 | |
| Contact: Tina Fortney 425-688-5000 | |
| Principal Investigator: Kathleen Gibson, MD | |
| Family Health Care of Ellensburg | Recruiting |
| Ellensburg, Washington, United States, 98926 | |
| Contact: Denise Michaud dbowman@fhcoe.com | |
| Principal Investigator: Byron Haney, MD | |
| Swedish Hospital | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Tracie Granger Tracie.Granger@swedish.org | |
| Sub-Investigator: Mark Reisman, MD | |
| Principal Investigator: Elizabeth Perpetua, ARNP | |
| Polyclinic | Recruiting |
| Seattle, Washington, United States, 98104 | |
| Contact: Kenita Davis 206-320-6766 | |
| Principal Investigator: Christopher Cannon, MD | |
| Franciscan Research Center | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Lisa Lundgren 253-426-6914 | |
| Principal Investigator: Tony Casanova, PharmD | |
| United States, Wisconsin | |
| Marshfield Clinic Research Foundation | Recruiting |
| Marshfield, Wisconsin, United States, 54449 | |
| Contact: Cindy Cloakley 715-387-5511 | |
| Principal Investigator: James Burmester, PhD | |
Sponsors and Collaborators
Iverson Genetic Diagnostics, Inc.
Investigators
| Principal Investigator: | An Pang Chieng, MD | Alhambra Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Iverson Genetic Diagnostics, Inc. |
| ClinicalTrials.gov Identifier: | NCT01305148 History of Changes |
| Other Study ID Numbers: | IG-0109 |
| Study First Received: | February 25, 2011 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Iverson Genetic Diagnostics, Inc.:
|
warfarin genetic testing personalized medicine anti-coagulants coumadin |
Additional relevant MeSH terms:
|
Warfarin Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013