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

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ClinicalTrials.gov Identifier: NCT01305148
Recruitment Status : Suspended (Sponsor is raising funds for the remainder of the study)
First Posted : February 28, 2011
Last Update Posted : August 31, 2015
Sponsor:
Information provided by (Responsible Party):
Iverson Genetic Diagnostics, Inc.

Tracking Information
First Submitted Date  ICMJE February 25, 2011
First Posted Date  ICMJE February 28, 2011
Last Update Posted Date August 31, 2015
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01305148 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2011)
  • 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)
  • 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)
  • Hemorrhagic Events [ Time Frame: 90 days ]
    The number of major hemorrhagic adverse events at 60 and at 90 days separately after warfarin initiation
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
Official Title  ICMJE Warfarin Adverse Event Reduction For Adults Receiving Genetic Testing at Therapy INitiation (WARFARIN)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Anti-coagulation Therapy
  • DVT
  • Pulmonary Embolism
  • Joint Surgery Multiple
  • Atrial Fibrillation
  • Prosthetic Replacement of Mitral Valve
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 25, 2013)
3800
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2011)
4300
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01305148
Other Study ID Numbers  ICMJE IG-0109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iverson Genetic Diagnostics, Inc.
Study Sponsor  ICMJE Iverson Genetic Diagnostics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: An Pang Chieng, MD Alhambra Hospital
PRS Account Iverson Genetic Diagnostics, Inc.
Verification Date August 2015

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