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Trial record 26 of 592 for:    WARFARIN

Clinical and Economic Implications of Genetic Testing for Warfarin Management

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ClinicalTrials.gov Identifier: NCT00964353
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : November 25, 2019
Last Update Posted : November 25, 2019
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
University of Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Blood Coagulation Disorders
Intervention Drug: Warfarin
Enrollment 359
Recruitment Details  
Pre-assignment Details Patients were deleted from the study due to patient delay of surgery, baseline INR being too high, patient rescheduling or canceling surgery, no INR ordered, no admission to hospital.
Arm/Group Title Control Experimental
Hide Arm/Group Description Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy. Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
Period Title: Overall Study
Started 181 178
Completed 181 178
Not Completed 0 0
Arm/Group Title Control Experimental Total
Hide Arm/Group Description

Estimated Effective Warfarin dosing calculations are based on clinical data algorithms

Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Estimated Effective Warfarin dosing calculations are based on genetic and clinical data algorithms.

Warfarin: Dose estimates will be suggested daily for initial dose given and up to 4 consecutive doses after initial dose.

Total of all reporting groups
Overall Number of Baseline Participants 181 178 359
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 178 participants 359 participants
18-39 years
19
  10.5%
20
  11.2%
39
  10.9%
40-60 years
55
  30.4%
75
  42.1%
130
  36.2%
61-75 years
77
  42.5%
60
  33.7%
137
  38.2%
75 years or more
30
  16.6%
23
  12.9%
53
  14.8%
[1]
Measure Description: Age categories are defined as 18-39, 40-60, 61-75, and 75 years and up.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 178 participants 359 participants
Female
111
  61.3%
93
  52.2%
204
  56.8%
Male
70
  38.7%
85
  47.8%
155
  43.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 178 participants 359 participants
Hispanic or Latino
10
   5.5%
7
   3.9%
17
   4.7%
Not Hispanic or Latino
171
  94.5%
170
  95.5%
341
  95.0%
Unknown or Not Reported
0
   0.0%
1
   0.6%
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants 178 participants 359 participants
American Indian or Alaska Native
0
   0.0%
2
   1.1%
2
   0.6%
Asian
0
   0.0%
1
   0.6%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
84
  46.4%
72
  40.4%
156
  43.5%
White
85
  47.0%
93
  52.2%
178
  49.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
12
   6.6%
10
   5.6%
22
   6.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 181 participants 178 participants 359 participants
181 178 359
1.Primary Outcome
Title Inpatient Length of Stay
Hide Description Inpatient length of stay
Time Frame during hospital stay, up to 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
Overall Number of Participants Analyzed 175 170
Mean (Standard Deviation)
Unit of Measure: days
6.8  (7.0) 7.2  (11.2)
2.Secondary Outcome
Title Supratherapeutic Dosing
Hide Description International Normalized Ratio
Time Frame during hospital stay, up to 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Experimental
Hide Arm/Group Description:
Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy.
Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
Overall Number of Participants Analyzed 175 170
Mean (Standard Deviation)
Unit of Measure: ratio
2.2  (0.2) 2.2  (0.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Experimental
Hide Arm/Group Description Control group received warfarin based on a clinically based dosing strategy during the first 6 days of therapy. Experimental arm received warfarin based on a genotype based therapy during the first 6 days of therapy.
All-Cause Mortality
Control Experimental
Affected / at Risk (%) Affected / at Risk (%)
Total   0/181 (0.00%)      2/178 (1.12%)    
Show Serious Adverse Events Hide Serious Adverse Events
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/181 (3.87%)      1/178 (0.56%)    
Cardiac disorders     
DVT or PE   7/181 (3.87%)  7 1/178 (0.56%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Experimental
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/181 (0.00%)      0/178 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr David Meltzer
Organization: University of Chicago
Phone: 773-702-0836
EMail: dmeltzer@medicine.bsd.uchicago.edu
Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00964353     History of Changes
Other Study ID Numbers: 16738B
First Submitted: August 12, 2009
First Posted: August 24, 2009
Results First Submitted: October 8, 2019
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019