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Trial record 46 of 734 for:    warfarin

Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)

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ClinicalTrials.gov Identifier: NCT00634907
Recruitment Status : Completed
First Posted : March 13, 2008
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
Gwen McMillin, University of Utah

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Venous Thromboembolism
Bleeding
Interventions Genetic: Pharmacogenetic-based warfarin dosing
Other: Usual care warfarin dosing
Enrollment 263
Recruitment Details Patients planning total hip or knee replacement surgery at the University of Utah Hospital, will be approached about participation in the study by Dr Chris Peters, MD or assigned orthopedic staff at the pre-operative office visit at the University of Utah Orthopaedic Center. Patients were enrolled from 9/27/06 - 10/2/08
Pre-assignment Details

Exclusion Criteria:

  1. Blood transfusion in previous two weeks
  2. Participant is already taking warfarin
  3. Pre-operative INR > 4.0
  4. Pre-operative bilirubin > 2.4 mg/dL
  5. Current active cancer diagnosis with ongoing treatment
  6. Concomitant medications known to exert a major interaction with warfarin
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Period Title: Overall Study
Started 131 132
Completed 114 115
Not Completed 17 17
Reason Not Completed
Withdrawal by Subject             3             0
Physician Decision             3             9
Withdrawal by Subject             11             8
Arm/Group Title Genotype-Based Dosing Arm Control Arm Total
Hide Arm/Group Description Initial warfarin dose calculated according to published Sconce algorithm Standard of care dosing Total of all reporting groups
Overall Number of Baseline Participants 114 115 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 115 participants 229 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
78
  68.4%
80
  69.6%
158
  69.0%
>=65 years
36
  31.6%
35
  30.4%
71
  31.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 115 participants 229 participants
58.18  (12.14) 59.25  (12.83) 58.75  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 115 participants 229 participants
Female
68
  59.6%
72
  62.6%
140
  61.1%
Male
46
  40.4%
43
  37.4%
89
  38.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 114 participants 115 participants 229 participants
114 115 229
1.Primary Outcome
Title The Number of Participants With Adverse Events Associated With Warfarin Anticoagulation Following Total Hip and Total Knee Replacement
Hide Description

Adverse events were defined as

  1. Major bleeding: fatal bleeding, bleeding into a critical organ, bleeding that requires hospital admission
  2. Minor bleeding: clinically overt bleeding not meeting criteria for major bleeding
  3. Symptomatic deep vein thrombosis (DVT)
  4. Pulmonary embolism (PE)
Time Frame 90 days post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Measure Type: Number
Unit of Measure: participants
2 4
2.Secondary Outcome
Title Percentage of Determinations in Therapuetic Range (INR 1.8-2.9)
Hide Description Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was between 1.8 and 2.9, the patient was considered to be "therapeutic." The proportion of INR determinations that fell within the therapeutic range (INR between 1.8-2.9) was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Measure Type: Number
Unit of Measure: percentage of therapeutic INR values
43.3 44.9
3.Secondary Outcome
Title Percentage of Determinations Subtherapeutic (INR<1.8)
Hide Description Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was less than 1.8, the patient was considered to be "subtherapeutic." The proportion of INR determination that were subtherapeutic was caluculated, per arm, based on the total number of INR determinations that were made during treatment with warfarin.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hop arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Measure Type: Number
Unit of Measure: percentage of deteminations
48.0 47.1
4.Secondary Outcome
Title Percentage of Determinations Supratherapeutic (INR>2.9)
Hide Description Patient response to warfarin was evaluated based on the international normalized ratio (INR), calculated from a prothrombin time blood test. When the INR value was greater than 2.9, the patient was considered to be "supratherapeutic." The proportion of INR determinations that were supratherapeutic was calculated, per arm, based on total number of INR determinations that were made during treatment with warfarin.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
Determinations were assessed cumulatively throughout the study period, per patient, per arm. The total number of determinations was 804 for the genotype arm and 780 for the control arm
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Measure Type: Number
Unit of Measure: percentage of determinations
8.7 8.0
5.Post-Hoc Outcome
Title Mean Number of Doses Before First Dose Adjustment
Hide Description The number of consistent doses administered before the first dose adjustment was required was recorded, per patient. The average number of doses administered before the first dose adjustment is shown.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Mean (Standard Deviation)
Unit of Measure: doses
3.1  (1.1) 3.6  (1.3)
6.Post-Hoc Outcome
Title Mean Number of Dose Adjustments
Hide Description The average number of dose adjustments made per patient, per arm, during the study period was calculated
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Mean (Standard Deviation)
Unit of Measure: doses
8.4  (2.18) 7.0  (2.48)
7.Post-Hoc Outcome
Title Percent of Patients With Dose Adjustments
Hide Description The percent of patients that required a dose adjustment during the study period was calculated.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Measure Type: Number
Unit of Measure: percentage of patients
83.5 78.0
8.Post-Hoc Outcome
Title Mean Number of Doses Required for the First Therapeutic INR
Hide Description The number of doses required to achieve a therapeutic INR (1.8-2.9) was determined per patient, per arm. The average was then calculated and is shown here.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Mean (Standard Deviation)
Unit of Measure: doses
3.9  (1.3) 3.4  (1.1)
9.Post-Hoc Outcome
Title Mean Number of Doses Before the First Supratherapeutic INR
Hide Description The number of warfarin doses administered before a patient INR exceeded the therapeutic range (>2.9) was recorded. The average was then calculated and is shown here.
Time Frame 2 weeks (knee arthroplasty) or 4 weeks (hip arthroplasty)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description:

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
Overall Number of Participants Analyzed 114 115
Mean (Standard Deviation)
Unit of Measure: doses administered
5.4  (2.1) 4.8  (1.9)
Time Frame Adverse events were recorded and investigated as they occurred, throughout the study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 Genotype Arm 1 Control Arm
Hide Arm/Group Description

The initial dose of warfarin will be corrected by the AC services team to account for variant genotypes, according to the following:

Sqrt (Dose) = 0.628 - 0.0135(Age) - 0.240(CYP2C9*2) - 0.370 (CYP2C9*3) - 0.241(VKORC1) + 0.0162(Height) Age: input age in years CYP2C9: input 0, 1, or 2 based on the number of variant alleles VKORC1: input 1 for GG, 2 for GA, and 3 for AA Height: input height in centimeters Patients in this study group will be managed by designated AC services physicians, different from those in managing patients in the Control Arm of this study. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2 daily during hospital stay, and 2 times weekly, or as needed, thereafter.

This is a two-armed parallel study with randomized assignment designed to test the hypothesis that selection of the initial warfarin dose based on CYP2C9 and VKORC1 genotypes will improve warfarin pharmacotherapy outcomes. Initial dose of warfarin will be given as per standard protocol for the Control Arm. Briefly, 3 or 5 mg warfarin will be administered on the day of surgery (post-operative day zero, POD#0) and the subsequent day. Patients in this study group will be managed by designated AC services physicians. Dosing adjustments will be made based on post-surgical INR values obtained initially on POD#2, daily during hospital stay, and 2 times weekly, or as needed, thereafter.
All-Cause Mortality
2 Genotype Arm 1 Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2 Genotype Arm 1 Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/114 (1.75%)      4/115 (3.48%)    
Vascular disorders     
Venous thromboembolic event or bleed  1  2/114 (1.75%)  2 4/115 (3.48%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, VTE
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2 Genotype Arm 1 Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/114 (0.88%)      6/115 (5.22%)    
Vascular disorders     
Minor bleed  [1]  1/114 (0.88%)  1 6/115 (5.22%)  6
Indicates events were collected by systematic assessment
[1]
Minor bleeds did not require hospitalization
Limited by the fact that INR was used to adjust dose at the third dose, which may not have allowed enough time for steady-state concentrations of warfarin to be achieved, nor for the genotype-based dosing to be adequately studied.
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: Dr. Gwen McMillin/Principal Investigator
Organization: University of Utah
Phone: 801-583-2787 ext 2671
EMail: gwen.mcmillin@aruplab.com
Layout table for additonal information
Responsible Party: Gwen McMillin, University of Utah
ClinicalTrials.gov Identifier: NCT00634907     History of Changes
Other Study ID Numbers: 00019469
First Submitted: February 6, 2008
First Posted: March 13, 2008
Results First Submitted: April 23, 2013
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017