BMS-562247 in Subjects Undergoing Elective Total Knee Replacement Surgery

Pulmonary Embolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097357
• Other study ID #: CV185-010
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 22, 2004
• Last updated: February 27, 2010
• Start date: October 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1238
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban
Tablets, Oral, 12 +/- 2 days
• Enoxaparin
Injection, SQ, Q12H, 12 +/- 2 days
• Warfarin
Tablets, Oral, QD, 12 +/- 2 days
• Enoxaparin Placebo
Injection, SQ, BID, 12 +/- 2 days
• Apixaban Placebo
Tablets, Oral, BID, 12 +/- 2 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  Denmark,  Israel,  Mexico,  Poland,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		throughout the study
Secondary	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		throughout the study
Secondary	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		throughout the study
Secondary	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		throughout the study
Secondary	To determine the pharmacokinetic (PK) profile of BMS-562247 and the relationship to dose and dose schedule		throughout the study

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm