Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

Overview[ - collapse ][ - ]

Purpose The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
ConditionDeep Vein Thrombosis
Pulmonary Embolism
InterventionDrug: Enoxaparin + Placebo
Drug: Apixaban + Placebo
PhasePhase 3
SponsorBristol-Myers Squibb
Responsible PartyBristol-Myers Squibb
ClinicalTrials.gov IdentifierNCT00452530
First ReceivedMarch 23, 2007
Last UpdatedFebruary 28, 2012
Last verifiedFebruary 2012

Tracking Information[ + expand ][ + ]

First Received DateMarch 23, 2007
Last Updated DateFebruary 28, 2012
Start DateJune 2007
Estimated Primary Completion DateJanuary 2009
Current Primary Outcome MeasuresA combination of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death [Time Frame: after 12 days of treatment] [Designated as safety issue: No]
Current Secondary Outcome MeasuresA combination of adjudicated asymptomatic and symptomatic proximal DVT, non-fatal PE, & VTE-related death [Time Frame: after 12 days of treatment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleStudy of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Official TitleA Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)
Brief Summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep
vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee
replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for
preventing these clots.

The safety of apixaban will also be studied.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition
  • Deep Vein Thrombosis
  • Pulmonary Embolism
InterventionDrug: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 40 mg, once daily, 12 days
Other Names:
Lovenox®Drug: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5mg, twice daily, 12 days
Other Names:
BMS-562247
Study Arm (s)
  • Active Comparator: A1
    + placebo
  • Experimental: A2
    + placebo

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment3054
Estimated Completion DateJanuary 2009
Estimated Primary Completion DateJanuary 2009
Eligibility Criteria
Inclusion Criteria:

- men and non-pregnant, non-breastfeeding women

- 18 years or older

- scheduled for total knee replacement surgery

Exclusion Criteria:

- hereditary or acquired bleeding disorders

- clotting disorders

- bleeding or high risk for bleeding

- drugs that affect bleeding or coagulation
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesAustria, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, France, Germany, Hungary, India, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Ukraine, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00452530
Other Study ID NumbersCV185-047
Has Data Monitoring CommitteeYes
Information Provided ByBristol-Myers Squibb
Study SponsorBristol-Myers Squibb
CollaboratorsNot Provided
Investigators Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification DateFebruary 2012

Locations[ + expand ][ + ]

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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Linz, Austria, 4010
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Wels, Austria, 4600
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Wien, Austria, 1090
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Wien, Austria, 1130
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Wiener Neustadt, Austria, 2700
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Antwerpen, Belgium, 2020
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Hasselt, Belgium, 3500
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Belo Horizonte - Mg, Minas Gerais, Brazil, 30130
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Sao Paulo, Brazil, 04023
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Santiago, Metropolitana, Chile, 7500922
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Santiago, Metropolitana, Chile, 8330033
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Beijing, Beijing, China, 100035
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Beijing, Beijing, China, 100835
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Qingdao, Shandong, China, 266003
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Shanghai, Shanghai, China, 200025
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Shanghai, Shanghai, China, 200233
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Shanghai, Shanghai, China, 200011
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Bogota, Colombia
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Bogota, Colombia, XXXXX
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Cali, Colombia, - - - - -
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Medelin, Colombia, -----
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Brno, Czech Republic, 662 50
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Chomutov, Czech Republic, 430 12
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Pardubice, Czech Republic, 532 03
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Prague 8, Czech Republic, 180 81
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Uherske Hradiste, Czech Republic, 686 68
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Hellerup, Denmark, 2900
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Hvidovre, Denmark, 2650
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Kolding, Denmark, 6000
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Viborg, Denmark, 8800
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Monaco, France, 98000
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Nice, France, 06200
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Paris, France, 75019
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Paris, France, 75679
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Paris, France, 75014
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Saint-Saulve, France, 59880
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Bad Mergentheim, Germany, 97980
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Bochum, Germany, 44791
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Brandenburg, Germany, 14770
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Dresden, Germany, 01307
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Frankfurt, Germany, 65929
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Frankfurt Am Main, Germany, 60528
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Halle/S, Germany, 06112
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Kremmen Ot Sommerfeld, Germany, 16766
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Rheinfelden, Germany, 79618
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Witten, Germany, 58455
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Szeged, Hungary, 6725
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Szekszard, Hungary, 7100
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Ahmedabad, Gujarat, India, 380054
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Ludhiana, Punjab, India, 141001
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Bangalore, India, 560034
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Baroda, India, 390007
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Mangalore, India, 575001
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Jeruselem, Israel, 91031
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Petach-Tikva, Israel, 49372
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Safed, Israel, 13110
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52621
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Abano Terme (Pd), Italy, 35031
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Bologna, Italy, 40136
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Pordenone, Italy, 33170
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Roma, Italy, 00168
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San Donato Milanese (Mi), Italy, 20097
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Jeonnam, Korea, Republic of, 519-809
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 138-736
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Seoul, Korea, Republic of, 136-705
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Kuala Lumpur, Malaysia, 56000
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Kuala Lumpur, Malaysia, 50586
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Zapopan, Jalisco, Mexico, 45200
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Hermosillo, Sonora, Mexico, 83190
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Aguascalientes, Mexico, 20010
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San Luis Potosi, Mexico, 78340
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Veracruz, Mexico, 91700
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Alesund, Norway, 6026
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Gjettum, Norway, 1346
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Kongsvinger, Norway, 2212
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Manila, Philippines, 1000
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Quezon City, Philippines, 1114
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Quezon City, Philippines, 1102
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Bytom, Poland, 41-902
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Gdansk, Poland, 80-803
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Warszawa, Poland, 03-242
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Wroclaw, Poland, 50-556
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Chelyabinsk, Russian Federation, 454021
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Kazan, Russian Federation, 420029
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Lipetsk, Russian Federation, 398035
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Moscow, Russian Federation, 115522
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Rostov-Na-Donu, Russian Federation, 344010
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Saint Petersburg, Russian Federation, 199106
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Saint Petersburg, Russian Federation, 194354
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Saint Petersburg, Russian Federation, 195427
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Saint Petersburg, Russian Federation, 193312
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Samara, Russian Federation, 443095
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Singapore, Singapore, 169608
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Singapore, Singapore, 529889
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Randburg, Free State, South Africa, 2194
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Johannesburg, Gauteng, South Africa, 2193
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Johannesburg, Gauteng, South Africa, 2031
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Pretoria, Gauteng, South Africa, 0083
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Somerset West, Western Cape, South Africa, 7130
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Tygerberg, Western Cape, South Africa, 7505
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Worcester, Western Cape, South Africa, 6850
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Badalona-Barcelona, Spain, 08916
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Barcelona, Spain, 08035
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Barcelona, Spain, 08006
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Barcelona, Spain, 08024
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Madrid, Spain, 28034
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Santiago De Compostela, Spain, 15706
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Valencia, Spain, 46010
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Boras, Sweden, 501 82
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Cherkassy, Ukraine, 18009
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Chernivtsy, Ukraine, 58013
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Dnipropetrovsk, Ukraine, 49005
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Ivano-Frankivsk, Ukraine, 76008
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Kyiv, Ukraine, 01601
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Kyiv, Ukraine, 04107
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Sevastopol, Ukraine, 99018
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London, Greater London, United Kingdom, SE5 9PJ
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Epsom, Surrey, United Kingdom, KT18 7EG