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

Primary Purpose

Anti-coagulation Therapy, DVT, Pulmonary Embolism

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Warfarin GenoSTAT Test
Sponsored by
Iverson Genetic Diagnostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anti-coagulation Therapy focused on measuring warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Veterans' Affairs Medical Center
  • Cardiovascular Consultants - Thunderbird
  • Cardiovascular Consultants - Phoenix
  • Orthoarkansas
  • Comprehensive Cardiovascular Specialists
  • St. Joseph's Medical Center
  • Colorado Heart & Vascular
  • Okaloosa Heart & Vascular
  • Infinity-Northshore
  • Infinity Clinical Research
  • Heart Rhythm Specialists
  • Sarasota Memorial Hospital
  • Grady Hospital
  • Cardiology of Atlanta
  • Atlanta Heart Group
  • Southern Heart Research Institute
  • St. Alphonsus Regional Medical Center
  • Rush University Medical Center
  • Rockford Cardiovascular Research Foundation
  • Carle Foundation
  • Community Hospital Anderson
  • St. Mary's
  • Medical Consultants, PC
  • NECCR
  • Henry Ford Hospital
  • Thoracic and Cardiovascular Institute
  • Kansas City Heart Foundation
  • Cox Medical Center
  • Billings Clinic
  • Nebraska Heart Institute
  • Nebraska Heart
  • Alegent
  • Hackensack Medical Center
  • New Mexico Heart Institute
  • Mission Hospital
  • Sanford Health Research
  • Aultman Hospital
  • The Christ Hospital
  • Bend Memorial Clinic
  • Corvallis Clinic
  • Central Bucks Cardiology
  • Palmetto Health Richland
  • Carolina Cardiology
  • St. Thomas Research Institute
  • Texas Cardiac Arrhythmia
  • Nexxus Research
  • Legacy Heart Center
  • Scott & White
  • Providence Health Network
  • Intermountain Medical Center
  • Overlake Hospital
  • Family Health Care of Ellensburg
  • Polyclinic
  • Swedish Hospital
  • Franciscan Research Center
  • Marshfield Clinic Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Randomized - Genetic

Randomized - Clinical

Registry

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

INR Tests
Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Warfarin Doses
Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Hemorrhagic Events
The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
Minor hemorrhagic events
The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
Major thromboembolic events
The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
INR tests
The percentage of the total INR tests performed in the first 30 days which are out of target range
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
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

Full Information

First Posted
February 25, 2011
Last Updated
August 27, 2015
Sponsor
Iverson Genetic Diagnostics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01305148
Brief Title
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Acronym
WARFARIN
Official Title
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Suspended
Why Stopped
Sponsor is raising funds for the remainder of the study
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iverson Genetic Diagnostics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anti-coagulation Therapy, DVT, Pulmonary Embolism, Joint Surgery Multiple, Atrial Fibrillation, Prosthetic Replacement of Mitral Valve
Keywords
warfarin, genetic testing, personalized medicine, anti-coagulants, coumadin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Randomized - Genetic
Arm Type
Experimental
Arm Description
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
Arm Title
Randomized - Clinical
Arm Type
No Intervention
Arm Description
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
Arm Title
Registry
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Warfarin GenoSTAT Test
Other Intervention Name(s)
Warfarin GenoSTAT, pharmacogenetic testing, personalized medicine
Intervention Description
Use of genetic information from the GenoSTAT test to determine the warfarin dose
Primary Outcome Measure Information:
Title
Incidence of warfarin related clinical events
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
INR Tests
Description
Comparison of the number of INR tests performed before warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Time Frame
30 days
Title
Warfarin Doses
Description
Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
Time Frame
90 days
Title
Hemorrhagic Events
Description
The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
Time Frame
90 days
Title
Minor hemorrhagic events
Description
The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
Time Frame
90 days
Title
Major thromboembolic events
Description
The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
Time Frame
90 days
Title
INR tests
Description
The percentage of the total INR tests performed in the first 30 days which are out of target range
Time Frame
30 days
Title
SF-12
Description
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
Time Frame
90 days
Title
Prescriber adherence
Description
Prescriber adherence to dosing recommendations through subject interview and comparison of dose recommendation to dose prescribed for the first four doses of warfarin
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
An Pang Chieng, MD
Organizational Affiliation
Alhambra Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Veterans' Affairs Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Cardiovascular Consultants - Thunderbird
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Cardiovascular Consultants - Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
Orthoarkansas
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Comprehensive Cardiovascular Specialists
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
St. Joseph's Medical Center
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Colorado Heart & Vascular
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Okaloosa Heart & Vascular
City
Crestview
State/Province
Florida
ZIP/Postal Code
32539
Country
United States
Facility Name
Infinity-Northshore
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Infinity Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Heart Rhythm Specialists
City
Naples
State/Province
Florida
ZIP/Postal Code
34119
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Cardiology of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Atlanta Heart Group
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Southern Heart Research Institute
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
St. Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Rockford Cardiovascular Research Foundation
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Carle Foundation
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Community Hospital Anderson
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
St. Mary's
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47750
Country
United States
Facility Name
Medical Consultants, PC
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
NECCR
City
Falls River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Thoracic and Cardiovascular Institute
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Kansas City Heart Foundation
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Cox Medical Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Nebraska Heart Institute
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Nebraska Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Alegent
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Facility Name
Hackensack Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
New Mexico Heart Institute
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Sanford Health Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44708
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Bend Memorial Clinic
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Corvallis Clinic
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Central Bucks Cardiology
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
Palmetto Health Richland
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Carolina Cardiology
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
St. Thomas Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texas Cardiac Arrhythmia
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Nexxus Research
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
Legacy Heart Center
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Scott & White
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Providence Health Network
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Overlake Hospital
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Family Health Care of Ellensburg
City
Ellensburg
State/Province
Washington
ZIP/Postal Code
98926
Country
United States
Facility Name
Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Franciscan Research Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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