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Trial record 12 of 226 for:    warfarin AND International

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

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ClinicalTrials.gov Identifier: NCT00993200
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : May 16, 2013
Last Update Posted : June 24, 2015
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
Robert Pendleton, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Blood Clotting
Interventions Genetic: warfarin pharmacogenetic dosing
Drug: Warfarin
Enrollment 26
Recruitment Details Twenty six subjects were enrolled and randomized
Pre-assignment Details Naive to warfarin were randomized to groups
Arm/Group Title Warfarin, Control Warfarin: PERMIT
Hide Arm/Group Description Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing. 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.
Period Title: Overall Study
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title Warfarin, Control Warfarin: PERMIT Total
Hide Arm/Group Description Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing. 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 of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
  46.2%
5
  38.5%
11
  42.3%
>=65 years
7
  53.8%
8
  61.5%
15
  57.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 13 participants 26 participants
45  (10) 59  (10) 52  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
6
  46.2%
6
  46.2%
12
  46.2%
Male
7
  53.8%
7
  53.8%
14
  53.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 13 participants 26 participants
13 13 26
1.Primary Outcome
Title The Number of Days to First International Normalized Ratio (INR) Within Therapeutic Range
Hide Description The number of days to first International Normalized Ratio (INR) is being measured from initiation of warfarin to the time when a subject first has an INR lab test result within +/- 0.5 of mean target INR range. The period during which this time interval could be measured is any time during the subject's warfarin therapy.
Time Frame variable as defined
Hide Outcome Measure Data
Hide Analysis Population Description
analysis per protocol
Arm/Group Title Standard PERMIT
Hide Arm/Group Description:
Standard of care warfarin management
Warfarin management with use of gene-based warfarin dosing algorithm
Overall Number of Participants Analyzed 13 13
Median (Standard Deviation)
Unit of Measure: days
8.3  (2) 4.7  (2)
2.Secondary Outcome
Title Adverse Major and Minor Bleeding Events
Hide Description Number of major and minor bleeding events
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin, Control Warfarin: PERMIT
Hide Arm/Group Description:
Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
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.
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: number of bleeding events
0 0
3.Secondary Outcome
Title Thrombotic Complication
Hide Description Number of thrombotic events
Time Frame 12 week
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Warfarin, Control Warfarin: PERMIT
Hide Arm/Group Description:
Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
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.
Overall Number of Participants Analyzed 13 13
Measure Type: Number
Unit of Measure: number of thrombotic events
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Warfarin, Control Warfarin: PERMIT
Hide Arm/Group Description Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing. 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.
All-Cause Mortality
Warfarin, Control Warfarin: PERMIT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Warfarin, Control Warfarin: PERMIT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Warfarin, Control Warfarin: PERMIT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/13 (0.00%)   0/13 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Pendleton
Organization: University of Utah
Phone: 801 581 7818
EMail: robert.pendleton@hsc.utah.edu
Layout table for additonal information
Responsible Party: Robert Pendleton, University of Utah
ClinicalTrials.gov Identifier: NCT00993200     History of Changes
Other Study ID Numbers: 35279
First Submitted: October 8, 2009
First Posted: October 12, 2009
Results First Submitted: August 13, 2012
Results First Posted: May 16, 2013
Last Update Posted: June 24, 2015