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Trial record 15 of 1105 for:    pharmacogenomics OR pharmacogenetics

Comparison of Warfarin Dosing Using Decision Model Versus Pharmacogenetic Algorithm

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ClinicalTrials.gov Identifier: NCT00511173
Recruitment Status : Completed
First Posted : August 3, 2007
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Atrial Fibrillation
Pulmonary Embolism
Deep Vein Thrombosis
Intervention Genetic: Warfarin Dose based on pharmacogenetics
Enrollment 102
Recruitment Details Subjects will be recruited from the warfarin clinic at the Creighton Cardiac Center from 7/06-6/07.
Pre-assignment Details  
Arm/Group Title Pharmacist Dosing
Hide Arm/Group Description Warfarin dose based on pharmacist dosing
Period Title: Overall Study
Started 102
Completed 102
Not Completed 0
Arm/Group Title Pharmacist Dosing
Hide Arm/Group Description Warfarin dose based on pharmacist dosing
Overall Number of Baseline Participants 102
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
<=18 years
0
   0.0%
Between 18 and 65 years
66
  64.7%
>=65 years
36
  35.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants
71  (12.3)
Age Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 102 participants
70
(49 to 82)
[1]
Measure Description: Age greater than 40 years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants
Female
46
  45.1%
Male
56
  54.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 102 participants
102
Baseline INR  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 102 participants
2.6  (.4)
warfarin dose  
Mean (Standard Deviation)
Unit of measure:  Mg/wk
Number Analyzed 102 participants
35.4  (16.4)
1.Primary Outcome
Title In Patients Receiving Warfarin, a Pharmacogenetic Algorithm Dose Was Compared to Clinician Dosing (mg/wk).
Hide Description Warfarin pharmacogenetic algorithm dosing (mg/wk) was compared to clinician warfarin dosing (mg/wk).
Time Frame six months
Hide Outcome Measure Data
Hide Analysis Population Description
power analysis based on data from Sconce, et al.
Arm/Group Title Algorithm Dosing Pharmacist Dosing
Hide Arm/Group Description:
Warfarin dose based on algorithm by Sconce, et al.
Warfarin dose based on clinician dosing
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: mg/wk
46.9  (7.5) 35.4  (16.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Algorithm Dosing, Pharmacist Dosing
Comments Null hypothesis: there is no difference in warfarin dose (mg/wk) between pharmacist dosing and algorithm dosing. In order to gather all SNP groups, the power analysis resulted in > 100 patients enrolled into each group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 10
Parameter Dispersion
Type: Standard Deviation
Value: 4.5
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pharmacist Dosing
Hide Arm/Group Description Warfarin dose based on pharmacist dosing
All-Cause Mortality
Pharmacist Dosing
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pharmacist Dosing
Affected / at Risk (%)
Total   0/102 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pharmacist Dosing
Affected / at Risk (%)
Total   0/102 (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: Christopher Destache
Organization: Creighton University
Phone: 402-280-4744
EMail: destache@creighton.edu
Layout table for additonal information
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00511173     History of Changes
Other Study ID Numbers: 06-14171
First Submitted: August 1, 2007
First Posted: August 3, 2007
Results First Submitted: April 17, 2012
Results First Posted: December 11, 2012
Last Update Posted: December 11, 2012