Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Hip Replacement Surgery (ADVANCE-3)
NCT ID: NCT00423319
Last Updated: 2014-05-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
5407 participants
INTERVENTIONAL
2007-03-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Apixaban, 2.5 mg BID plus placebo
Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Enoxaparin-matching placebo
Administered as injection
Enoxaparin, 40 mg QD plus placebo
Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Apixaban-matching placebo
Administered as oral tablets
Interventions
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Enoxaparin
Subcutaneous, 40 mg, once daily, 5 weeks
Apixaban
Oral tablets, 2.5 mg, twice daily, 5weeks
Enoxaparin-matching placebo
Administered as injection
Apixaban-matching placebo
Administered as oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who were willing and able to undergo bilateral ascending contrast venography
* Either sex, any race, 18 years and older
Exclusion Criteria
* Known or suspected history of heparin-induced thrombocytopenia
* Known coagulopathy
* Active bleeding or at high risk for bleeding
* Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
* Active hepatobiliary disease
* Alcohol and/or substance abuse within the past year
* Any condition for which surgery or administration of an anticoagulant is contraindicated
* Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure \>180 mm Hg or supine diastolic blood pressure \>105 mm Hg
* Clinically significant laboratory abnormalities at the enrollment visit:
* Hemoglobin \<10 g/dL
* Platelet count \<100,000/mm\^3
* Creatinine clearance \<30 mL/min, as estimated by the method of Cockcroft and Gault
* Alanine aminotransferase or aspartate aminotransferase \>2\*upper limit of normal or a total bilirubin ≥ 1.5\*1 (unless an alternative causative factor such as Gilbert's syndrome was identified)
* Need for ongoing treatment with a parenteral or oral anticoagulant (eg, subjects with mechanical valves, warfarin eligible atrial fibrillation)
* Current use of dextrans or fibrinolytics
* Treatment with medications affecting coagulation or platelet function
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
West Alabama Research, Llc
Birmingham, Alabama, United States
Martin Bowen Hefley Orthopedics
Little Rock, Arkansas, United States
Orthoarkansas, P.A.
Little Rock, Arkansas, United States
Uc Davis Medical Center
Sacramento, California, United States
Colorado Orthopedic Consultants, Pc
Aurora, Colorado, United States
Advanced Orthopedic And Sports Medicine Specilists
Denver, Colorado, United States
Denver-Vail Orthopedics, P.C.
Denver, Colorado, United States
Pab Clinical Research
Brandon, Florida, United States
Research Alliance, Inc.
Clearwater, Florida, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, United States
Phoenix Clinical Research, Llc
Tamarac, Florida, United States
Atlanta Knee And Sports Medicine
Decatur, Georgia, United States
Americana Orthopedics
Boise, Idaho, United States
Bosie Orthopedic Clinic
Meridian, Idaho, United States
University Orthopedic Center
Altoona, Pennsylvania, 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
Capital Federal, 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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Ciudad de Buenos Aires, Buenos Aires, Argentina
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Coronel Suárez, Buenos Aires, Argentina
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Monte Grande, Buenos Aires, Argentina
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Camperdown, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Lismore, New South Wales, Australia
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Southport, Queensland, Australia
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Malvern, Victoria, Australia
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Windsor, Victoria, Australia
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Perth, Western Australia, Australia
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Antwerp, , Belgium
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Brasschaat, , Belgium
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Genk, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Edmonton, Alberta, Canada
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Ajax, Ontario, Canada
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Cambridge, Ontario, Canada
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Chatham, Ontario, Canada
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Guelph, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Sarnia, 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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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Qingdao, Shandong, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Shanghai, Shanghai Municipality, China
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Amager, , Denmark
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Frederiksberg, , Denmark
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Herlev, , Denmark
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Hvidovre, , Denmark
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Hørsholm, , Denmark
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København NV, , Denmark
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Silkeborg, , Denmark
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Nice, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Saint-Etienne, , France
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Saint-Saulve, , France
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Rheinfelden, , Germany
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Budapest, , Hungary
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Kecskemét, , Hungary
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Szeged, , Hungary
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Szolnok, , Hungary
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Ahmedabad, Gujarat, India
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Ludhiana, Punjab, India
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Lucknow, Uttar Prsdesh, India
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Bangalore, , India
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Mangalore, , India
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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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Ẕerifin, , Israel
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Aguascalientes, Aguascalientes, Mexico
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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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Mexico City, Mexico City, Mexico
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Ciudad Madero, Tamaulipas, Mexico
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Gjettum, , Norway
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Kongsvinger, , Norway
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Lillehammer, , Norway
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Tynset, , Norway
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Tønsberg, , Norway
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Gdansk, , Poland
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Lodz, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Chelyabinsk, , Russia
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Kazan', , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Yaroslavl, , Russia
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Badalona-Barcelone, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Gothenburg, , Sweden
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Stockholm, , Sweden
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Cherkassy, , Ukraine
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Chernivtsy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Sevastopol, , Ukraine
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London, Greater London, United Kingdom
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Wigan, Lancashire, United Kingdom
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Epsom, Surrey, United Kingdom
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.
Pineo GF, Gallus AS, Raskob GE, Chen D, Ramirez LM, Ramacciotti E, Lassen MR, Wang L. Apixaban after hip or knee arthroplasty versus enoxaparin: efficacy and safety in key clinical subgroups. J Thromb Haemost. 2013 Mar;11(3):444-51. doi: 10.1111/jth.12109.
Lassen MR, Gallus A, Raskob GE, Pineo G, Chen D, Ramirez LM; ADVANCE-3 Investigators. Apixaban versus enoxaparin for thromboprophylaxis after hip replacement. N Engl J Med. 2010 Dec 23;363(26):2487-98. doi: 10.1056/NEJMoa1006885.
Other Identifiers
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CV185-035
Identifier Type: -
Identifier Source: org_study_id
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