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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Iverson Genetic Diagnostics, Inc.
Sponsor:
Information provided by (Responsible Party):
Iverson Genetic Diagnostics, Inc.
ClinicalTrials.gov Identifier:
NCT01305148
First received: February 25, 2011
Last updated: September 23, 2014
Last verified: September 2014
  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
Anti-coagulation Therapy
DVT
Pulmonary Embolism
Joint Surgery Multiple
Atrial Fibrillation
Prosthetic Replacement of Mitral Valve
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 2015
Estimated Primary Completion Date: December 2015 (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:
  • 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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305148

Contacts
Contact: Dean Sproles dean@iversongenetics.com

  Show 59 Study Locations
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: September 23, 2014
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:
Atrial Fibrillation
Pulmonary Embolism
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Embolism
Embolism and Thrombosis
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014