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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00097357




Registration number
NCT00097357
Ethics application status
Date submitted
22/11/2004
Date registered
23/11/2004
Date last updated
2/03/2010

Titles & IDs
Public title
BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery
Scientific 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
Secondary ID [1] 0 0
CV185-010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thrombosis 0 0
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Warfarin
Treatment: Drugs - Enoxaparin Placebo
Treatment: Drugs - Apixaban Placebo

Experimental: A1 - Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A2 - Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A3 - Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo

Experimental: A4 - Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo

Experimental: A5 - Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo

Experimental: A6 - Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo

Active comparator: E1 - Enoxaparin: 30 mg

PLUS

Apixaban Placebo

Active comparator: W1 - Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0


Treatment: Drugs: Apixaban
Tablets, Oral, 12 +/- 2 days

Treatment: Drugs: Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days

Treatment: Drugs: Warfarin
Tablets, Oral, QD, 12 +/- 2 days

Treatment: Drugs: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days

Treatment: Drugs: Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
throughout the study
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
throughout the study
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
throughout the study
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
throughout the study
Secondary outcome [4] 0 0
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Timepoint [4] 0 0
throughout the study

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
1238
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Camperdown
Recruitment hospital [2] 0 0
Local Institution - Chermside
Recruitment hospital [3] 0 0
Local Institution - Gold Coast
Recruitment hospital [4] 0 0
Local Institution - Herston
Recruitment hospital [5] 0 0
Local Institution - Bedford Park
Recruitment hospital [6] 0 0
Local Institution - Box Hill
Recruitment hospital [7] 0 0
Local Institution - Clayton
Recruitment hospital [8] 0 0
Local Institution - East Ringwood
Recruitment hospital [9] 0 0
Local Institution - Geelong
Recruitment hospital [10] 0 0
Local Institution - Windsor
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Chermside
Recruitment postcode(s) [3] 0 0
- Gold Coast
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Bedford Park
Recruitment postcode(s) [6] 0 0
- Box Hill
Recruitment postcode(s) [7] 0 0
- Clayton
Recruitment postcode(s) [8] 0 0
- East Ringwood
Recruitment postcode(s) [9] 0 0
- Geelong
Recruitment postcode(s) [10] 0 0
- Windsor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Idaho
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
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Louisiana
Country [14] 0 0
United States of America
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Maryland
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United States of America
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Massachusetts
Country [16] 0 0
United States of America
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Michigan
Country [17] 0 0
United States of America
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Mississippi
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United States of America
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New York
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North Carolina
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United States of America
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Ohio
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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South Carolina
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Texas
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Virginia
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Mendoza
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Frederiksberg
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Denmark
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Herlev
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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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Israel
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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
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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
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Mexico
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Baja California Sur
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Distrito Federal
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Estado De Mexico
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Jalisco
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Nuevo Leon
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Sinaloa
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Sonora
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Tamaulipas
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Veracruz
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Mexico
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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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Poland
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Bialystock
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Poland
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Gdansk
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Piekary Slaskie
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Poland
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Radom
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Poland
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Sosnowiec
Country [67] 0 0
Poland
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Szczecin Zdunowo
Country [68] 0 0
Poland
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Szczecin
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Poland
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Warszawa
Country [70] 0 0
Puerto Rico
State/province [70] 0 0
Ponce

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00097357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00097357