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

August 27, 2015 updated by: Iverson Genetic Diagnostics, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Veterans' Affairs Medical Center
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Cardiovascular Consultants - Thunderbird
      • Phoenix, Arizona, United States, 85015
        • Cardiovascular Consultants - Phoenix
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • OrthoArkansas
    • California
      • Alhambra, California, United States, 91801
        • Comprehensive Cardiovascular Specialists
      • Stockton, California, United States, 95204
        • St. Joseph's Medical Center
    • Colorado
      • Denver, Colorado, United States, 80204
        • Colorado Heart & Vascular
    • Florida
      • Crestview, Florida, United States, 32539
        • Okaloosa Heart & Vascular
      • Fort Lauderdale, Florida, United States, 33313
        • Infinity-Northshore
      • Hollywood, Florida, United States, 33021
        • Infinity Clinical Research
      • Naples, Florida, United States, 34119
        • Heart Rhythm Specialists
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Grady Hospital
      • Atlanta, Georgia, United States, 30328
        • Cardiology of Atlanta
      • Decatur, Georgia, United States, 30033
        • Atlanta Heart Group
      • Riverdale, Georgia, United States, 30274
        • Southern Heart Research Institute
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Alphonsus Regional Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Rockford, Illinois, United States, 61107
        • Rockford Cardiovascular Research Foundation
      • Urbana, Illinois, United States, 61801
        • Carle Foundation
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Community Hospital Anderson
      • Evansville, Indiana, United States, 47750
        • St. Mary's
      • Muncie, Indiana, United States, 47303
        • Medical Consultants, Pc
    • Massachusetts
      • Falls River, Massachusetts, United States, 02720
        • NECCR
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Lansing, Michigan, United States, 48910
        • Thoracic and Cardiovascular Institute
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Kansas City Heart Foundation
      • Springfield, Missouri, United States, 65807
        • Cox Medical Center
    • Montana
      • Billings, Montana, United States, 59101
        • Billings Clinic
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Nebraska Heart Institute
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart
      • Omaha, Nebraska, United States, 68124
        • Alegent
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mission Hospital
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Sanford Health Research
    • Ohio
      • Canton, Ohio, United States, 44708
        • Aultman Hospital
      • Cincinnati, Ohio, United States, 45219
        • The Christ Hospital
    • Oregon
      • Bend, Oregon, United States, 97701
        • Bend Memorial Clinic
      • Corvallis, Oregon, United States, 97330
        • Corvallis Clinic
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Central Bucks Cardiology
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Palmetto Health Richland
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Cardiology
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Research Institute
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia
      • Bedford, Texas, United States, 76021
        • Nexxus Research
      • Plano, Texas, United States, 75024
        • Legacy Heart Center
      • Temple, Texas, United States, 76508
        • Scott & White
      • Waco, Texas, United States, 76712
        • Providence Health Network
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Hospital
      • Ellensburg, Washington, United States, 98926
        • Family Health Care of Ellensburg
      • Seattle, Washington, United States, 98104
        • Polyclinic
      • Seattle, Washington, United States, 98122
        • Swedish Hospital
      • Tacoma, Washington, United States, 98405
        • Franciscan Research Center
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Research Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:
  • Warfarin GenoSTAT
  • pharmacogenetic testing
  • personalized medicine
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:
  • Warfarin GenoSTAT
  • pharmacogenetic testing
  • personalized medicine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of warfarin related clinical events
Time Frame: 30 days
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
INR Tests
Time Frame: 30 days
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
Time Frame: 90 days
Comparison of the cumulative warfarin dose necessary to reach warfarin dose stabilization (i.e. two consecutive INR tests within the target range)
90 days
Hemorrhagic Events
Time Frame: 90 days
The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
90 days
Minor hemorrhagic events
Time Frame: 90 days
The number of minor hemorrhagic adverse events at 30, 60 and at 90 days separately after warfarin initiation
90 days
Major thromboembolic events
Time Frame: 90 days
The number of major thromboembolic adverse events at 60 and at 90 days separately after warfarin initiation for
90 days
INR tests
Time Frame: 30 days
The percentage of the total INR tests performed in the first 30 days which are out of target range
30 days
SF-12
Time Frame: 90 days
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
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iverson Genetic Diagnostics, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: An Pang Chieng, MD, Alhambra Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IG-0109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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