Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

Condition(s) targeted: Anti-coagulation Therapy; DVT; Pulmonary Embolism; Joint Surgery Multiple; Atrial Fibrillation; Prosthetic Replacement of Mitral Valve

Intervention: Warfarin GenoSTAT Test (Device)

Phase: N/A

Status: Recruiting

Sponsored by: Iverson Genetic Diagnostics, Inc.

Official(s) and/or principal investigator(s):
An Pang Chieng, MD, Principal Investigator, Affiliation: Alhambra Hospital

Overall contact:
Dave Hammond, Email: daveh@iversongenetics.com

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.

Official title: Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Incidence of warfarin related clinical events

Secondary outcome:

INR Tests

Warfarin Doses

Hemorrhagic Events

Minor hemorrhagic events

Major thromboembolic events

INR tests

SF-12

Prescriber adherence

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Dave Hammond, Email: daveh@iversongenetics.com

Veterans' Affairs Medical Center, Birmingham, Alabama 35233, United States; Recruiting
Pamela Parker, MD, Phone: 205-933-8101
Pamela Parker, MD, Principal Investigator

Cardiovascular Consultants - Thunderbird, Glendale, Arizona 85306, United States; Terminated

Cardiovascular Consultants - Phoenix, Phoenix, Arizona 85015, United States; Terminated

Orthoarkansas, Little Rock, Arkansas 72205, United States; Terminated

Comprehensive Cardiovascular Specialists, Alhambra, California 91801, United States; Recruiting
Debbie Lai, NP, Phone: 626-281-8663
Peter Fung, MD, Principal Investigator

Palo Alto Medical Foundation, Palo Alto, California 94301, United States; Withdrawn

St. Joseph's Medical Center, Stockton, California 95204, United States; Recruiting
Teri Kozik, PhD, Phone: 209-943-2000
Teri Kozik, PhD, Principal Investigator

Colorado Heart & Vascular, Denver, Colorado 80204, United States; Recruiting
Dana Long, Phone: 303-522-3745
Sameer Mehta, MD, Principal Investigator

Okaloosa Heart & Vascular, Crestview, Florida 32539, United States; Recruiting
Barbara Sierra, Phone: 850-682-7212
Juan Zarate, MD, Principal Investigator

Infinity-Northshore, Fort Lauderdale, Florida 33313, United States; Recruiting
Alex Saenz, Phone: 786-552-2180
Alam Schwartz, MD, Principal Investigator

Infinity Clinical Research, Hollywood, Florida 33021, United States; Recruiting
Rebecca Nemhard, Phone: 945-965-4900
Ann Robblee, PAC, Principal Investigator

Heart Rhythm Specialists, Naples, Florida 34119, United States; Recruiting
Carlos Davison, MD, Phone: 239-348-4290
Carlos Davison, MD, Principal Investigator

Sarasota Memorial Hospital, Sarasota, Florida 34239, United States; Recruiting
Amanda Miller, RN, Phone: 941-917-6164
Kirk Voelker, MD, Principal Investigator

Cardiology of Atlanta, Atlanta, Georgia 30328, United States; Recruiting
Pat Rudolph, Phone: 404-252-7970
Hector Malave, MD, Principal Investigator

Grady Hospital, Atlanta, Georgia 30303, United States; Terminated

Atlanta Heart Group, Decatur, Georgia 30033, United States; Terminated

Southern Heart Research Institute, Riverdale, Georgia 30274, United States; Terminated

St. Alphonsus Regional Medical Center, Boise, Idaho 83702, United States; Recruiting
Nichole Whitener, Phone: 208-367-2121
Antonio Lopez, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Sherri Velez, Phone: 312-942-3696
Gezer, MD, Principal Investigator

Rockford Cardiovascular Research Foundation, Rockford, Illinois 61107, United States; Recruiting
Joanne Carner, Phone: 815-847-5835
Farhod Farokhi, MD, Principal Investigator

Carle Foundation, Urbana, Illinois 61801, United States; Recruiting
Tiffany McGeehon, Phone: 217-337-2000
Sanjay Mehta, MD, Principal Investigator

Community Hospital Anderson, Anderson, Indiana 46011, United States; Recruiting
Brandie Preston, Email: brandie.preston@ecommunity.com
Preetham Jetty, MD, Principal Investigator

St. Mary's, Evansville, Indiana 47750, United States; Terminated

Medical Consultants, PC, Muncie, Indiana 47303, United States; Recruiting
Haley Morgan, Phone: 765-281-2166
Jennifer Bow, NP, Principal Investigator

NECCR, Falls River, Massachusetts 02720, United States; Recruiting
Jacqueline Difazio, Phone: 508-672-7450
Wajid Baig, MD, Principal Investigator

Henry Ford Hospital, Detroit, Michigan 48202, United States; Recruiting
Susan Maddox, RN, Email: SMADDOX1@hfhs.org
Vinay Shah, MD, Principal Investigator

Thoracic and Cardiovascular Institute, Lansing, Michigan 48910, United States; Terminated

Kansas City Heart Foundation, Kansas City, Missouri 64114, United States; Recruiting
Barb Lee, Email: barb.lee@kchf.org
John Lee, MD, Principal Investigator

Cox Medical Center, Springfield, Missouri 65807, United States; Recruiting
Kaitlin Gilbert, Phone: 416-269-0598
Steven Rowe, Principal Investigator

Billings Clinic, Billings, Montana 59101, United States; Terminated

Nebraska Heart Institute, Grand Island, Nebraska 68803, United States; Recruiting
Dawn Carpenter, Phone: 800-644-3627
Douglas Kosmicki, MD, Principal Investigator

Nebraska Heart, Lincoln, Nebraska 68526, United States; Recruiting
Corey Godfrey, Phone: 402-328-3928
Dennis Kosmicki, MD, Principal Investigator

Alegent, Omaha, Nebraska 68124, United States; Recruiting
Jacque Taylor, Phone: 402-343-8515
Himanshu Agarwal, MD, Principal Investigator

Hackensack Medical Center, Hackensack, New Jersey 07601, United States; Terminated

New Mexico Heart Institute, Albuquerque, New Mexico 87102, United States; Recruiting
Jill Atkins, Phone: 505-843-2813
Ross Downey, MD, Principal Investigator

Mission Hospital, Asheville, North Carolina 28801, United States; Recruiting
Leslie Shell, RN, Phone: 828-213-7993
Scott Joslin, MD, Principal Investigator

Sanford Health Research, Fargo, North Dakota 58122, United States; Recruiting
Amber Leach, Phone: 701-234-5899
Susan Farkas, MD, Principal Investigator

Aultman Hospital, Canton, Ohio 44708, United States; Recruiting
Rachel Senter, Phone: 330-489-9053
Ira Friedlander, MD, Principal Investigator

The Christ Hospital, Cincinnati, Ohio 45219, United States; Recruiting
Gina Knecht, Email: Gina.Knecht@thechristhospital.com
Philip Leming, MD, Principal Investigator

Bend Memorial Clinic, Bend, Oregon 97701, United States; Terminated

Corvallis Clinic, Corvallis, Oregon 97330, United States; Terminated

University Orthopedics Center, Altoona, Pennsylvania 16602, United States; Withdrawn

Central Bucks Cardiology, Doylestown, Pennsylvania 18901, United States; Recruiting
Donna Taylor, Phone: 215-345-1900, Ext: 300
Michael Mooradd, MD, Principal Investigator

Palmetto Health Richland, Columbia, South Carolina 29203, United States; Recruiting
Georgia Welnick, Phone: 803-434-7000
Solomon Chesoni, MD, Principal Investigator

Carolina Cardiology, Rock Hill, South Carolina 29732, United States; Recruiting
Beth Martinotti, Phone: 803-324-5135
Talal Baki, MD, Principal Investigator

St. Thomas Research Institute, Nashville, Tennessee 37205, United States; Terminated

Texas Cardiac Arrhythmia, Austin, Texas 78705, United States; Recruiting
Kathryn Morgan, Phone: 512-807-3150
Javier Sanchez, MD, Principal Investigator

Nexxus Research, Bedford, Texas 76021, United States; Recruiting
Amy Culpepper, Phone: 817-358-9806
David Kaner, DO, Principal Investigator

Odyssey Research, Bedford, Texas 76021, United States; Withdrawn

Legacy Heart Center, Plano, Texas 75024, United States; Recruiting
Tonya Goldston, Email: tgoldston@legacyheartcenter.com
Marcus McKenzie, MD, Principal Investigator

Scott & White, Temple, Texas 76508, United States; Terminated

Providence Health Network, Waco, Texas 76712, United States; Recruiting
Samina Ali, Phone: 254-399-5400
Sherwin Attai, MD, Principal Investigator

Intermountain Medical Center, Murray, Utah 84157, United States; Recruiting
Valerie Aston, RN, Phone: 801-507-4606
Scott Woller, MD, Principal Investigator

Overlake Hospital, Bellevue, Washington 98004, United States; Recruiting
Tina Fortney, Phone: 425-688-5000
Kathleen Gibson, MD, Principal Investigator

Family Health Care of Ellensburg, Ellensburg, Washington 98926, United States; Recruiting
Denise Michaud, Email: dbowman@fhcoe.com
Byron Haney, MD, Principal Investigator

Polyclinic, Seattle, Washington 98104, United States; Recruiting
Kenita Davis, Phone: 206-320-6766
Christopher Cannon, MD, Principal Investigator

Swedish Hospital, Seattle, Washington 98122, United States; Terminated

Franciscan Research Center, Tacoma, Washington 98405, United States; Recruiting
Lisa Lundgren, Phone: 253-426-6914
Tony Casanova, PharmD, Principal Investigator

Marshfield Clinic Research Foundation, Marshfield, Wisconsin 54449, United States; Terminated

WARFARIN Study main website

Starting date: August 2011
Last updated: December 24, 2014