Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
NCT ID: NCT00452530
Last Updated: 2014-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3221 participants
INTERVENTIONAL
2007-06-30
2009-01-31
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
TREATMENT
DOUBLE
Study Groups
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Apixaban, 2.5 mg BID + Placebo
Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
Apixaban
2.5 mg, administered twice daily as tablets, for 12 days
Enoxaparin-matching placebo
Administered once daily by subcutaneous injection
Enoxaparin, 40 mg QD + Placebo
Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
Enoxaparin
40 mg, administered once daily by subcutaneous injection, for 12 days
Apixaban-matching placebo
Oral tablet administered twice daily
Interventions
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Enoxaparin
40 mg, administered once daily by subcutaneous injection, for 12 days
Apixaban
2.5 mg, administered twice daily as tablets, for 12 days
Enoxaparin-matching placebo
Administered once daily by subcutaneous injection
Apixaban-matching placebo
Oral tablet administered twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients willing and able to undergo bilateral ascending contrast venography
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, in the opinion of the investigator, surgery or administration of an anticoagulant was 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 level \>2\*upper limit of normal (ULN) or a total bilirubin ≥1.5\*ULN (unless an alternative causative factor such as Gilbert's syndrome was identified)
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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Graz, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Vienna, , Austria
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Vienna, , Austria
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Wels, , Austria
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Wiener Neustadt, , Austria
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Antwerp, , Belgium
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Hasselt, , Belgium
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Belo Horizonte - Mg, Minas Gerais, Brazil
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São Paulo, São Paulo, Brazil
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Santiago, Santiago Metropolitan, Chile
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Santiago, Santiago Metropolitan, Chile
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, 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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Bogotá, , Colombia
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Bogotá, , Colombia
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Cali, , Colombia
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Medellín, , Colombia
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Brno, , Czechia
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Chomutov, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Hellerup, , Denmark
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Hvidovre, , Denmark
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Kolding, , Denmark
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Viborg, , Denmark
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Monaco, , France
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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-Saulve, , France
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Bad Mergentheim, , Germany
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Bochum, , Germany
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Brandenburg, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Frankfurt am Main, , Germany
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Halle/S, , Germany
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Kremmen Ot Sommerfeld, , Germany
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Rheinfelden, , Germany
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Witten, , Germany
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Szeged, , Hungary
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Szekszárd, , Hungary
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Ahmedabad, Gujarat, India
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Ludhiana, Punjab, India
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Bangalore, , India
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Baroda, , India
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Mangalore, , India
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Jeruselem, , Israel
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Petah Tikva, , Israel
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Safed, , Israel
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Tel Aviv, , Israel
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Tel Litwinsky, , Israel
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Abano Terme (Pd), , Italy
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Bologna, , Italy
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Pordenone, , Italy
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Roma, , Italy
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San Donato Milanese (Mi), , Italy
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Aguascalientes, Aguascalientes, Mexico
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Zapopan, Jalisco, Mexico
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San Luis Potosí City, San Luis Potosí, Mexico
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Hermosillo, Sonora, Mexico
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Veracruz, Veracruz, Mexico
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Ålesund, , Norway
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Gjettum, , Norway
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Kongsvinger, , Norway
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Manila, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Bytom, , Poland
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Gdansk, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Chelyabinsk, , Russia
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Kazan', , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Rostov-on-Don, , 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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Singapore, , Singapore
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Singapore, , Singapore
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Randburg, Free State, South Africa
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Johannesburg, Gauteng, South Africa
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Somerset West, Western Cape, South Africa
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Tygerberg, Western Cape, South Africa
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Worcester, Western Cape, South Africa
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Jeonnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Badalona-Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Borås, , 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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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, Raskob GE, Gallus A, Pineo G, Chen D, Hornick P; ADVANCE-2 investigators. Apixaban versus enoxaparin for thromboprophylaxis after knee replacement (ADVANCE-2): a randomised double-blind trial. Lancet. 2010 Mar 6;375(9717):807-15. doi: 10.1016/S0140-6736(09)62125-5.
Related Links
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Investigator Inquiry form
Other Identifiers
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EUdraCT: 2006-006896-19
Identifier Type: -
Identifier Source: secondary_id
CV185-047
Identifier Type: -
Identifier Source: org_study_id
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