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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 24, 2014
Last verified: December 2014

February 25, 2011
December 24, 2014
August 2011
December 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01305148 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Anti-coagulation Therapy
  • DVT
  • Pulmonary Embolism
  • Joint Surgery Multiple
  • Atrial Fibrillation
  • Prosthetic Replacement of Mitral Valve
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
  • 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
    Intervention: Device: Warfarin GenoSTAT Test
  • 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
    Intervention: Device: Warfarin GenoSTAT Test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3800
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Dave Hammond daveh@iversongenetics.com
United States
 
NCT01305148
IG-0109
Yes
Iverson Genetic Diagnostics, Inc.
Iverson Genetic Diagnostics, Inc.
Not Provided
Principal Investigator: An Pang Chieng, MD Alhambra Hospital
Iverson Genetic Diagnostics, Inc.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP