Venous ThrombosisPhase 2/3NCT00097357

BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

A Phase 2/3 study testing Apixaban, Enoxaparin and Warfarin in people with Venous Thrombosis and Pulmonary Embolism, run by Bristol-Myers Squibb at 147 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Venous Thrombosis, Pulmonary Embolism
What is being tested?: Apixaban, Enoxaparin and Warfarin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,238 participants
Where: 147 sitesin 9 countries
Study dates: Oct 2004to Dec 2005
Phase: Phase 2/3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

147 sites in 9 countries.

Country

City, postcode or hospital

147 sites in 9 countries

United States72 sites

Local Institution
Atlanta, Georgia
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Aurora, Colorado
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Austin, Texas
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Baltimore, Maryland
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Bay Pines, Florida
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Beverly Hills, California
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Birmingham, Alabama
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Boise, Idaho
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Brandon, Florida
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Buffalo, New York
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Charleston, South Carolina
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Charlotte, North Carolina
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Cincinnati, Ohio
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Clearwater, Florida
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Covington, Louisiana
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Cumming, Georgia
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Dallas, Texas
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Decatur, Georgia
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DeLand, Florida
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Denver, Colorado
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Encinitas, California
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Fort Myers, Florida
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Fountain Valley, California
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Galesburg, Illinois
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Hartford, Connecticut
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Havertown, Pennsylvania
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Hollywood, Florida
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Houston, Texas
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Jackson, Mississippi
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La Jolla, California
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La Mesa, California
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Lexington, Kentucky
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Little Rock, Arkansas
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Long Beach, California
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Lubbock, Texas
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Madisonville, Kentucky
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Marshfield, Wisconsin
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Melbourne, Florida
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Meridian, Idaho
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Mobile, Alabama
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Monroe, North Carolina
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Montclair, California
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Newport News, Virginia
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Newton, Massachusetts
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Northport, Alabama
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Oakland, California
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Pasadena, California
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Pensacola, Florida
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Port Huron, Michigan
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Sacramento, California
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San Antonio, Texas
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San Bernardino, California
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San Diego, California
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Santa Monica, California
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Sarasota, Florida
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Scottsdale, Arizona
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Seattle, Washington
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Springfield, Illinois
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St. Petersburg, Florida
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Suwanee, Georgia
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Tallahassee, Florida
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Torrance, California
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Tucson, Arizona
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Tulsa, Oklahoma
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Wichita, Kansas
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Wildomar, California
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Winter Park, Florida
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Youngstown, Ohio
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Yuba City, California

Other trials in United States

Canada23 sites

Local Institution
Ajax, Ontario
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Burlington, Ontario
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Calgary, Alberta
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Dartmouth, Nova Scotia
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Edmonton, Alberta
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Greater Sudbury, Ontario
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Kelowna, British Columbia
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Montreal, Quebec
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Newmarket, Ontario
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Niagara Falls, Ontario
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Oakville, Ontario
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Red Deer, Alberta
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Richmond Hill, Ontario
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St. Catharines, Ontario
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Ste-foy, Quebec
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Thunder Bay, Ontario
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Toronto, Ontario
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Vancouver, British Columbia
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Victoriaville, Quebec
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Waterloo, Ontario
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Welland, Ontario
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Weston, Ontario
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Windsor, Ontario

Other trials in Canada

Mexico13 sites

Local Institution
Aguascalientes, Aguascalientes
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Chihuahua City, Chihuahua
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Culiacán, Sinaloa
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Guadalajara, Jalisco
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Hermosillo, Sonora
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Jalapa, Veracruz
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Mérida, Yucatán
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México, State of Mexico
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Mexico City, Mexico City
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Monterrey, Nuevo León
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Tampico, Tamps, Tamaulipas
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Tijuana, Baja California Sur
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Veracruz, Veracruz

Other trials in Mexico

Australia10 sites

Local Institution
Bedford Park, South Australia
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Box Hill, Victoria
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Camperdown, New South Wales
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Chermside, Queensland
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Clayton, Victoria
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East Ringwood, Victoria
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Geelong, Victoria
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Gold Coast, Queensland
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Herston, Queensland
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Windsor, Victoria

Other trials in Australia

Poland10 sites

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Bialystock
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Gdansk
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Lodz
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Lublin
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Piekary Śląskie
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Radom
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Sosnowiec
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Szczecin
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Szczecin Zdunowo
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Warsaw

Other trials in Poland

Israel8 sites

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Haifa
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Holon
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Kfar Saba
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Petah Tikva
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Ramat Gan
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Rehovot
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Tel Aviv
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Tsrifin

Other trials in Israel

Argentina5 sites

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Buenos Aires, Buenos Aires
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Capital fEDERAL, Buenos Aires
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Godoy Cruz, Mendoza Province
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Mendoza, Mendoza Province
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Prov. Buenos Aires, Buenos Aires

Other trials in Argentina

Denmark5 sites

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Frederiksberg
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Herlev
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Hørsholm
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Silkeborg
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Slagelse

Other trials in Denmark

Puerto Rico1 site

Local Institution
Ponce

Other trials in Puerto Rico

About this study

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

Conditions: Venous Thrombosis, Pulmonary Embolism
Being tested: Apixaban, Enoxaparin, Warfarin, Enoxaparin Placebo, Apixaban Placebo
Keywords: Prevention of deep vein thrombosis and pulmonary embolism, Preventive therapy
Medical subject headings: Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ApixabanDrug
Also called BMS-562247
Tablets, Oral, 12 +/- 2 days
EnoxaparinDrug
Injection, SQ, Q12H, 12 +/- 2 days
WarfarinDrug
Tablets, Oral, QD, 12 +/- 2 days
Enoxaparin PlaceboDrug
Injection, SQ, BID, 12 +/- 2 days
Apixaban PlaceboDrug
Tablets, Oral, BID, 12 +/- 2 days

Study groups in NCT00097357
Study group	Role	What they receive
A1	Experimental	Apixaban: 2.5 mg, BID PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
A2	Experimental	Apixaban: 5 mg, BID PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
A3	Experimental	Apixaban: 10 mg, BID PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
A4	Experimental	Apixaban: 5 mg, QD PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
A5	Experimental	Apixaban: 10 mg, QD PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
A6	Experimental	Apixaban: 20 mg, QD PLUS Enoxaparin Placebo Receives: Drug: Apixaban; Drug: Enoxaparin Placebo
E1	Active comparator	Enoxaparin: 30 mg PLUS Apixaban Placebo Receives: Drug: Enoxaparin; Drug: Apixaban Placebo
W1	Active comparator	Warfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0 Receives: Drug: Warfarin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: throughout the study

Secondary outcomes (4)

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
Measured: 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
Measured: 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
Measured: throughout the study
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Measured: throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2004Dec 2005

First posted23 Nov 2004 (estimated)
Study startOct 2004
Primary completionDec 2005
Study completionDec 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Venous ThrombosisStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,238 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00097357
Sponsor's protocol ID: CV185-010
Status last verified: Nov 2008
First submitted: 22 Nov 2004
Last updated: 2 Mar 2010
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Venous Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00097357
Acronym / sponsor ID: CV185-010
Conditions: Venous Thrombosis, Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism, Preventive therapy
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,238 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Dec 2005 (actual)
Study completion: Dec 2005 (actual)
First posted: 23 Nov 2004 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
A1	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 2.5 mg, BID PLUS Enoxaparin Placebo
A2	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 5 mg, BID PLUS Enoxaparin Placebo
A3	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 10 mg, BID PLUS Enoxaparin Placebo
A4	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 5 mg, QD PLUS Enoxaparin Placebo
A5	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 10 mg, QD PLUS Enoxaparin Placebo
A6	Experimental	Drug: Apixaban, Drug: Enoxaparin PlaceboApixaban: 20 mg, QD PLUS Enoxaparin Placebo
E1	Active comparator	Drug: Enoxaparin, Drug: Apixaban PlaceboEnoxaparin: 30 mg PLUS Apixaban Placebo
W1	Active comparator	Drug: WarfarinWarfarin: 5 mg tablets dose titrated to a targeted INR of 1.8 to 3.0

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ApixabanAlso: BMS-562247Tablets, Oral, 12 +/- 2 days	Drug	A1, A2, A3, A4, A5, A6
EnoxaparinInjection, SQ, Q12H, 12 +/- 2 days	Drug	E1
WarfarinTablets, Oral, QD, 12 +/- 2 days	Drug	W1
Enoxaparin PlaceboInjection, SQ, BID, 12 +/- 2 days	Drug	A1, A2, A3, A4, A5, A6
Apixaban PlaceboTablets, Oral, BID, 12 +/- 2 days	Drug	E1

Primary outcome

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

4 secondary outcomes

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
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
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
To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule
Time frame: throughout the study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.

Related trials for Venous Thrombosis

Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Danang Cerebral Venous Thrombosis Registry
Cerebral Venous Sinus Thrombosis, Stroke
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
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Not yet recruitingPhase 4
Iopidine to Decrease Intraocular Pressure Rise After Injections
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

147 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Apixaban, Enoxaparin and Warfarin in people with Venous Thrombosis and Pulmonary Embolism, run by Bristol-Myers Squibb at 147 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Canada, Mexico, Australia, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00097357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.