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Personalized Medicine Interface Tool (PerMIT): Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy

This study has been completed.
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Robert Pendleton, University of Utah
ClinicalTrials.gov Identifier:
NCT00993200
First received: October 8, 2009
Last updated: April 8, 2013
Last verified: April 2013
Results First Received: August 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Blood Clotting
Interventions: Genetic: warfarin pharmacogenetic dosing
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty six subjects were enrolled and randomized

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Naive to warfarin were randomized to groups

Reporting Groups
  Description
Warfarin, Control Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
Warfarin: PERMIT Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.

Participant Flow:   Overall Study
    Warfarin, Control     Warfarin: PERMIT  
STARTED     13     13  
COMPLETED     13     13  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Warfarin, Control Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
Warfarin: PERMIT Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
Total Total of all reporting groups

Baseline Measures
    Warfarin, Control     Warfarin: PERMIT     Total  
Number of Participants  
[units: participants]
  13     13     26  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     6     5     11  
>=65 years     7     8     15  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 10     59  ± 10     52  ± 10  
Gender  
[units: participants]
     
Female     6     6     12  
Male     7     7     14  
Region of Enrollment  
[units: participants]
     
United States     13     13     26  



  Outcome Measures
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1.  Primary:   The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range   [ Time Frame: variable as defined ]

2.  Secondary:   Adverse Major and Minor Bleeding Events   [ Time Frame: 12 week ]

3.  Secondary:   Thrombotic Complication   [ Time Frame: 12 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small sample size in this pilot trial


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert Pendleton
Organization: University of Utah
phone: 801 581 7818
e-mail: robert.pendleton@hsc.utah.edu


No publications provided


Responsible Party: Robert Pendleton, University of Utah
ClinicalTrials.gov Identifier: NCT00993200     History of Changes
Other Study ID Numbers: 35279
Study First Received: October 8, 2009
Results First Received: August 13, 2012
Last Updated: April 8, 2013
Health Authority: United States: Institutional Review Board