BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

February 27, 2010 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Local Institution
    • Buenos Aires
      • CAPITAL fEDERAL, Buenos Aires, Argentina
        • Local Institution
      • Prov. Buenos Aires, Buenos Aires, Argentina
        • Local Institution
    • Mendoza
      • Ciudad De Mendoza, Mendoza, Argentina
        • Local Institution
      • Godoy Cruz, Mendoza, Argentina
        • Local Institution
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Local Institution
    • Queensland
      • Chermside, Queensland, Australia
        • Local Institution
      • Gold Coast, Queensland, Australia
        • Local Institution
      • Herston, Queensland, Australia
        • Local Institution
    • South Australia
      • Bedford Park, South Australia, Australia
        • Local Institution
    • Victoria
      • Box Hill, Victoria, Australia
        • Local Institution
      • Clayton, Victoria, Australia
        • Local Institution
      • East Ringwood, Victoria, Australia
        • Local Institution
      • Geelong, Victoria, Australia
        • Local Institution
      • Windsor, Victoria, Australia
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Local Institution
      • Edmonton, Alberta, Canada
        • Local Institution
      • Red Deer, Alberta, Canada
        • Local Institution
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Local Institution
      • Vancouver, British Columbia, Canada
        • Local Institution
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada
        • Local Institution
    • Ontario
      • Ajax, Ontario, Canada
        • Local Institution
      • Burlington, Ontario, Canada
        • Local Institution
      • Newmarket, Ontario, Canada
        • Local Institution
      • Niagara Falls, Ontario, Canada
        • Local Institution
      • Oakville, Ontario, Canada
        • Local Institution
      • Richmond Hill, Ontario, Canada
        • Local Institution
      • St. Catharines, Ontario, Canada
        • Local Institution
      • Sudbury, Ontario, Canada
        • Local Institution
      • Thunder Bay, Ontario, Canada
        • Local Institution
      • Toronto, Ontario, Canada
        • Local Institution
      • Waterloo, Ontario, Canada
        • Local Institution
      • Welland, Ontario, Canada
        • Local Institution
      • Weston, Ontario, Canada
        • Local Institution
      • Windsor, Ontario, Canada
        • Local Institution
    • Quebec
      • Montreal, Quebec, Canada
        • Local Institution
      • Ste-foy, Quebec, Canada
        • Local Institution
      • Victoriaville, Quebec, Canada
        • Local Institution
  • Denmark
      • Frederiksberg, Denmark
        • Local Institution
      • Herlev, Denmark
        • Local Institution
      • Horsholm, Denmark
        • Local Institution
      • Silkeborg, Denmark
        • Local Institution
      • Slagelse, Denmark
        • Local Institution
  • Israel
      • Haifa, Israel
        • Local Institution
      • Holon, Israel
        • Local Institution
      • Kfar Saba, Israel
        • Local Institution
      • Petach-tikva, Israel
        • Local Institution
      • Ramat Gan, Israel
        • Local Institution
      • Rehovot, Israel
        • Local Institution
      • Tel Aviv, Israel
        • Local Institution
      • Zerifin, Israel
        • Local Institution
  • Mexico
      • Aguascalientes, Mexico
        • Local Institution
      • Chihuahua, Mexico
        • Local Institution
      • Veracruz, Mexico
        • Local Institution
    • Baja California Sur
      • Tijuana, Baja California Sur, Mexico
        • Local Institution
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Local Institution
      • Mexico City, Distrito Federal, Mexico
        • Local Institution
    • Estado De Mexico
      • Mexico, Estado De Mexico, Mexico
        • Local Institution
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico
        • Local Institution
    • Sinaloa
      • Culiacan, Sinaloa, Mexico
        • Local Institution
    • Sonora
      • Hermosillo, Sonora, Mexico
        • Local Institution
    • Tamaulipas
      • Tampico, Tamps, Tamaulipas, Mexico
        • Local Institution
    • Veracruz
      • Jalapa, Veracruz, Mexico
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico
        • Local Institution
  • Poland
      • Bialystock, Poland
        • Local Institution
      • Gdansk, Poland
        • Local Institution
      • Lodz, Poland
        • Local Institution
      • Lublin, Poland
        • Local Institution
      • Piekary Slaskie, Poland
        • Local Institution
      • Radom, Poland
        • Local Institution
      • Sosnowiec, Poland
        • Local Institution
      • Szczecin, Poland
        • Local Institution
      • Szczecin Zdunowo, Poland
        • Local Institution
      • Warszawa, Poland
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Local Institution
      • Mobile, Alabama, United States
        • Local Institution
      • Northport, Alabama, United States
        • Local Institution
    • Arizona
      • Phoenix, Arizona, United States
        • Local Institution
      • Scottsdale, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • Arkansas
      • Little Rock, Arkansas, United States
        • Local Institution
    • California
      • Beverly Hills, California, United States
        • Local Institution
      • Encinitas, California, United States
        • Local Institution
      • Fountain Valley, California, United States
        • Local Institution
      • La Jolla, California, United States
        • Local Institution
      • La Mesa, California, United States
        • Local Institution
      • Long beach, California, United States
        • Local Institution
      • Montclair, California, United States
        • Local Institution
      • Oakland, California, United States
        • Local Institution
      • Pasadena, California, United States
        • Local Institution
      • Sacramento, California, United States
        • Local Institution
      • San Bernardino, California, United States
        • Local Institution
      • San Diego, California, United States
        • Local Institution
      • Santa Monica, California, United States
        • Local Institution
      • Torrance, California, United States
        • Local Institution
      • Wildomar, California, United States
        • Local Institution
      • Yuba City, California, United States
        • Local Institution
    • Colorado
      • Aurora, Colorado, United States
        • Local Institution
      • Denver, Colorado, United States
        • Local Institution
    • Connecticut
      • Hartford, Connecticut, United States
        • Local Institution
    • Florida
      • Bay Pines, Florida, United States
        • Local Institution
      • Brandon, Florida, United States
        • Local Institution
      • Clearwater, Florida, United States
        • Local Institution
      • Deland, Florida, United States
        • Local Institution
      • Ft. Myers, Florida, United States
        • Local Institution
      • Hollywood, Florida, United States
        • Local Institution
      • Melbourne, Florida, United States
        • Local Institution
      • Pensacola, Florida, United States
        • Local Institution
      • Sarasota, Florida, United States
        • Local Institution
      • St. Petersburg, Florida, United States
        • Local Institution
      • Tallahassee, Florida, United States
        • Local Institution
      • Winter Park, Florida, United States
        • Local Institution
    • Georgia
      • Atlanta, Georgia, United States
        • Local Institution
      • Cumming, Georgia, United States
        • Local Institution
      • Decatur, Georgia, United States
        • Local Institution
      • Suwanee, Georgia, United States
        • Local Institution
    • Idaho
      • Boise, Idaho, United States
        • Local Institution
      • Meridian, Idaho, United States
        • Local Institution
    • Illinois
      • Galesburg, Illinois, United States
        • Local Institution
      • Springfield, Illinois, United States
        • Local Institution
    • Kansas
      • Wichita, Kansas, United States
        • Local Institution
    • Kentucky
      • Lexington, Kentucky, United States
        • Local Institution
      • Madisonville, Kentucky, United States
        • Local Institution
    • Louisiana
      • Covington, Louisiana, United States
        • Local Institution
    • Maryland
      • Baltimore, Maryland, United States
        • Local Institution
    • Massachusetts
      • Newton, Massachusetts, United States
        • Local Institution
    • Michigan
      • Port Huron, Michigan, United States
        • Local Institution
    • Mississippi
      • Jackson, Mississippi, United States
        • Local Institution
    • New York
      • Buffalo, New York, United States
        • Local Institution
    • North Carolina
      • Charlotte, North Carolina, United States
        • Local Institution
      • Monroe, North Carolina, United States
        • Local Institution
    • Ohio
      • Cincinnati, Ohio, United States
        • Local Institution
      • Youngstown, Ohio, United States
        • Local Institution
    • Oklahoma
      • Tulsa, Oklahoma, United States
        • Local Institution
    • Pennsylvania
      • Havertown, Pennsylvania, United States
        • Local Institution
      • Philadelphia, Pennsylvania, United States
        • Local Institution
      • Pittsburgh, Pennsylvania, United States
        • Local Institution
    • South Carolina
      • Charleston, South Carolina, United States
        • Local Institution
    • Texas
      • Austin, Texas, United States
        • Local Institution
      • Dallas, Texas, United States
        • Local Institution
      • Houston, Texas, United States
        • Local Institution
      • Lubbock, Texas, United States
        • Local Institution
      • San Antonio, Texas, United States
        • Local Institution
    • Virginia
      • Newport News, Virginia, United States
        • Local Institution
    • Washington
      • Seattle, Washington, United States
        • Local Institution
    • Wisconsin
      • Marshfield, Wisconsin, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A1

Apixaban: 2.5 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A2

Apixaban: 5 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A3

Apixaban: 10 mg, BID

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A4

Apixaban: 5 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A5

Apixaban: 10 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Experimental: A6

Apixaban: 20 mg, QD

PLUS

Enoxaparin Placebo
Drug: Apixaban
Tablets, Oral, 12 +/- 2 days
Other Names:
  • BMS-562247
Drug: Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
Active Comparator: E1

Enoxaparin: 30 mg

PLUS

Apixaban Placebo
Drug: Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
Drug: Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days
Active Comparator: W1
Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0
Drug: Warfarin
Tablets, Oral, QD, 12 +/- 2 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
throughout the study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
throughout the study
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
throughout the study
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
throughout the study
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CV185-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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