Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT ID: NCT00371683
Last Updated: 2015-12-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
3608 participants
INTERVENTIONAL
2006-11-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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A1
\+ placebo
Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
A2
\+ placebo
Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
Interventions
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Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Scheduled for knee replacement surgery
Exclusion Criteria
* clotting disorders
* bleeding or high risk for bleeding
* drugs that affect bleeding or coagulation
* need for ongoing parenteral or oral anticoagulation
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Capstone Clinical Trials, Inc
Birmingham, Alabama, United States
Capstone Clinical Trials, Inc
Birmingham, Alabama, United States
West Alabama Research, Inc.
Tuscaloosa, Alabama, United States
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
Colorado Orthopedic Consultants, Pc
Aurora, Colorado, United States
Colorado Joint Replacement
Denver, Colorado, United States
Jdpmedical Research
Denver, Colorado, United States
Orhtopaedic Physicians Of Colorado, P.C.
Englewood, Colorado, United States
Orthopedics Assocs Of Hartford
Hartford, Connecticut, United States
Anthony S. Unger, Md
Washington D.C., District of Columbia, United States
Bay Pines Va Medical Center
Bay Pines, Florida, United States
Pab Clinical Research
Brandon, Florida, United States
Jacksonville Center For Clinical Research
Jacksonville, Florida, United States
Mark W. Hollmann, Md
Orange City, Florida, United States
Jewett Orthopaedic Clinic
Winter Park, Florida, United States
Atlanta Knee And Sports Medicine
Decatur, Georgia, United States
Americana Orthopedics
Boise, Idaho, United States
Intermountain Orthopaedics
Boise, Idaho, United States
Bluegrass Orthopaedics/Bmr
Lexington, Kentucky, United States
Charleston Orthopaedic Assocs.
Charleston, South Carolina, United States
Kelsey Seybold Clinic
Houston, Texas, United States
Bone & Joint Clinic Of Houston
Houston, Texas, United States
Gill Orthopedic Center
Lubbock, Texas, United States
Robert R. King, Md
Lubbock, Texas, United States
Unlimited Research
San Antonio, Texas, United States
Local Institution
Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Capital Federal, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Garran, Australian Capital Territory, Australia
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Camperdown, New South Wales, Australia
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Caringbah, New South Wales, Australia
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Lismore, New South Wales, Australia
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Gold Coast, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Windsor, Victoria, Australia
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Perth, Western Australia, Australia
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rs, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Edmonton, Alberta, Canada
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Ajax, Ontario, Canada
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Burlington, Ontario, Canada
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Cambridge, Ontario, Canada
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Chatham, Ontario, Canada
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Dartmouth, Ontario, Canada
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Guelph, Ontario, Canada
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Lindsay, Ontario, Canada
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Newmarket, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Sarnia, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Scarborough Village, Ontario, Canada
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St. Catharines, Ontario, Canada
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Stratford, Ontario, Canada
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Waterloo, Ontario, Canada
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Windsor, Ontario, Canada
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Charlottetown, Prince Edward Island, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Hørsholm, , Denmark
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Kopenhamn S, , Denmark
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Kecskemét, , Hungary
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Székesfehérvár, , Hungary
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Szolnok, , Hungary
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Afula, , Israel
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Beersheba, , Israel
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Haifa, , Israel
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Holon, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Ẕerifin, , Israel
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Chihuahua City, Chihuahua, Mexico
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Tijuana, Estado de Baja California, Mexico
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Guadalajara, Jalisco, Mexico
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Df, Mexico City, Mexico
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Df, Mexico City, Mexico
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Df, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
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Ciudad Madero, Tamaulipas, Mexico
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Jalapa, Veracruz, Mexico
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Mérida, Yucatán, Mexico
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Mérida, Yucatán, Mexico
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Bialystok, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Gothenburg, , Sweden
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Adana, , Turkey (Türkiye)
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Bursa, , Turkey (Türkiye)
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Mersin, , Turkey (Türkiye)
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Trabzon, , Turkey (Türkiye)
Countries
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References
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Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16.
Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604. doi: 10.1056/NEJMoa0810773.
Other Identifiers
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CV185-034
Identifier Type: -
Identifier Source: org_study_id