Back to resultsBMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Primary Purpose
Venous Thrombosis, Pulmonary Embolism
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Apixaban
Enoxaparin
Warfarin
Enoxaparin Placebo
Apixaban Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thrombosis focused on measuring Prevention of deep vein thrombosis and pulmonary embolism, Preventive therapy
Eligibility Criteria
Inclusion Criteria: Undergoing elective unilateral total knee replacement surgery. Willing and able to undergo bilateral ascending contrast venography. Able to inject (by self or caregiver) study medication subcutaneously. Exclusion Criteria: Women of childbearing potential. Women who are pregnant or breastfeeding. Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2
Sites / Locations
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Arm Label
A1
A2
A3
A4
A5
A6
E1
W1
Arm Description
Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo
Apixaban: 5 mg, BID PLUS Enoxaparin Placebo
Apixaban: 10 mg, BID PLUS Enoxaparin Placebo
Apixaban: 5 mg, QD PLUS Enoxaparin Placebo
Apixaban: 10 mg, QD PLUS Enoxaparin Placebo
Apixaban: 20 mg, QD PLUS Enoxaparin Placebo
Enoxaparin: 30 mg PLUS Apixaban Placebo
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Outcomes
Primary Outcome Measures
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
Secondary Outcome Measures
Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Full Information
NCT ID
NCT00097357
First Posted
November 22, 2004
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00097357
Brief Title
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Official Title
A Phase 2 Randomized, Double-Blinded (BMS-562247 and Enoxaparin), Active-Controlled (Enoxaparin and Warfarin), Parallel-Arm, Dose-Response Study of the Oral Factor Xa Inhibitor BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to learn if BMS-562247 can prevent blood clots in the legs and lungs in men and women following unilateral total knee replacement surgery. The safety of this treatment will also be studied.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thrombosis, Pulmonary Embolism
Keywords
Prevention of deep vein thrombosis and pulmonary embolism, Preventive therapy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A1
Arm Type
Experimental
Arm Description
Apixaban: 2.5 mg, BID
PLUS
Enoxaparin Placebo
Arm Title
A2
Arm Type
Experimental
Arm Description
Apixaban: 5 mg, BID
PLUS
Enoxaparin Placebo
Arm Title
A3
Arm Type
Experimental
Arm Description
Apixaban: 10 mg, BID
PLUS
Enoxaparin Placebo
Arm Title
A4
Arm Type
Experimental
Arm Description
Apixaban: 5 mg, QD
PLUS
Enoxaparin Placebo
Arm Title
A5
Arm Type
Experimental
Arm Description
Apixaban: 10 mg, QD
PLUS
Enoxaparin Placebo
Arm Title
A6
Arm Type
Experimental
Arm Description
Apixaban: 20 mg, QD
PLUS
Enoxaparin Placebo
Arm Title
E1
Arm Type
Active Comparator
Arm Description
Enoxaparin: 30 mg
PLUS
Apixaban Placebo
Arm Title
W1
Arm Type
Active Comparator
Arm Description
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
BMS-562247
Intervention Description
Tablets, Oral, 12 +/- 2 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Injection, SQ, Q12H, 12 +/- 2 days
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Tablets, Oral, QD, 12 +/- 2 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin Placebo
Intervention Description
Injection, SQ, BID, 12 +/- 2 days
Intervention Type
Drug
Intervention Name(s)
Apixaban Placebo
Intervention Description
Tablets, Oral, BID, 12 +/- 2 days
Primary Outcome Measure Information:
Title
Determine the dose-response relationship among the 3 QD and 3 BID doses of BMS-562247 on the composite endpoint of adjudicated VTE events and all-cause death in subjects treated with study medication for 12 +/-2 days following surgery
Time Frame
throughout the study
Secondary Outcome Measure Information:
Title
Assess the effect of QD and BID dose of BMS-562247 vs subcutaneous 30 mg q12h enoxaparin and warfarin on the composite endpoint of adjudication VTE events and all-cause death in subjects treated for 12 +/-2 days following surgery
Time Frame
throughout the study
Title
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated major bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
Time Frame
throughout the study
Title
Assess the effect of each QD and BID dose of BMS-562247 versus subcutaneous 30 mg q12h enoxaparin and oral warfarin on the incidence of adjudicated minor bleeding events in subjects treated with study medication for 12 +/-2 days following surgery
Time Frame
throughout the study
Title
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Time Frame
throughout the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing elective unilateral total knee replacement surgery.
Willing and able to undergo bilateral ascending contrast venography.
Able to inject (by self or caregiver) study medication subcutaneously.
Exclusion Criteria:
Women of childbearing potential.
Women who are pregnant or breastfeeding.
Under some conditions, subjects weighing more than 300 lbs. (136kg) and/or Body Mass Index (BMI) >=35 kg/m2
Facility Information:
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Birmingham
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Newport News
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Marshfield
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Buenos Aires
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Argentina
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Prov. Buenos Aires
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Buenos Aires
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Argentina
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Ciudad De Mendoza
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Mendoza
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Argentina
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Godoy Cruz
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Mendoza
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Argentina
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Buenos Aires
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Argentina
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Camperdown
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New South Wales
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Australia
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Chermside
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Queensland
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Australia
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Gold Coast
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Queensland
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Australia
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Herston
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Queensland
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Australia
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Bedford Park
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South Australia
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Australia
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Box Hill
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Victoria
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Australia
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Clayton
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Victoria
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Australia
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East Ringwood
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Victoria
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Australia
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Geelong
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Victoria
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Australia
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Windsor
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Victoria
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Australia
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Calgary
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Alberta
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Canada
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Edmonton
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Alberta
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Canada
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Red Deer
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Alberta
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Canada
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Kelowna
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British Columbia
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Canada
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Vancouver
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British Columbia
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Dartmouth
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Ajax
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Burlington
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Newmarket
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Niagara Falls
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Oakville
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Richmond Hill
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St. Catharines
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Sudbury
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Thunder Bay
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Toronto
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Waterloo
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Welland
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Weston
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Windsor
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Montreal
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Ste-foy
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Victoriaville
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Quebec
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Canada
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Frederiksberg
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Denmark
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Herlev
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Denmark
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Horsholm
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Denmark
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Silkeborg
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Denmark
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Slagelse
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Denmark
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Haifa
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Israel
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Holon
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Israel
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Kfar Saba
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Israel
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Petach-tikva
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Israel
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Ramat Gan
Country
Israel
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Rehovot
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Israel
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Tel Aviv
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Israel
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Zerifin
Country
Israel
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Tijuana
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Baja California Sur
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Mexico
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Mexico City
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Distrito Federal
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Mexico
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Mexico
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Distrito Federal
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Mexico
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Mexico
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Estado De Mexico
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Mexico
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Guadalajara
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Jalisco
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Mexico
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Monterrey
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Nuevo Leon
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Mexico
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Culiacan
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Sinaloa
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Mexico
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Hermosillo
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Sonora
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Mexico
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Tampico, Tamps
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Tamaulipas
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Mexico
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Jalapa
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Veracruz
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Mexico
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Merida
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Yucatan
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Mexico
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Aguascalientes
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Mexico
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Chihuahua
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Mexico
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Veracruz
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Mexico
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Bialystock
Country
Poland
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Gdansk
Country
Poland
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Lodz
Country
Poland
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Lublin
Country
Poland
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Piekary Slaskie
Country
Poland
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Radom
Country
Poland
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Sosnowiec
Country
Poland
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Szczecin Zdunowo
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Poland
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Local Institution
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Szczecin
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Poland
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Local Institution
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Warszawa
Country
Poland
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Local Institution
City
Ponce
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
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