Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
NCT ID: NCT00332020
Last Updated: 2015-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2457 participants
INTERVENTIONAL
2006-02-28
2007-06-30
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
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
Arm 2
Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days
Interventions
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Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days
Eligibility Criteria
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Inclusion Criteria
* Patients scheduled for elective total hip replacement
Exclusion Criteria
* Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
* Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
* Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, Alabama, United States
Denver, Colorado, United States
Bay Pines, Florida, United States
Miami, Florida, United States
Oklahoma City, Oklahoma, United States
Canberra, Australian Capital Territory, Australia
Lismore, New South Wales, Australia
Sydney, New South Wales, Australia
Southport, Queensland, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Curitiba, Paraná, Brazil
Passo Fundo, Rio Grande do Sul, Brazil
Batatais, São Paulo, Brazil
Marília, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Red Deer, Alberta, Canada
Penticton, British Columbia, Canada
Winnipeg, Manitoba, Canada
Saint John, New Brunswick, Canada
Oshawa, Ontario, Canada
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Scarborough Village, Ontario, Canada
Scarborough Village, Ontario, Canada
Thunder Bay, Ontario, Canada
Windsor, Ontario, Canada
Guangzhou, Guangdong, China
Jinan, Shandong, China
Qingdao, Shandong, China
Xi’an, Shanxi, China
Beijing, , China
Beijing, , China
Beijing, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Shanghai, , China
Barranquilla, , Colombia
Bogotá, , Colombia
Cali, , Colombia
Medellín, , Colombia
Copenhagen, , Denmark
Copenhagen, , Denmark
Frederiksberg, , Denmark
Glostrup Municipality, , Denmark
Herlev, , Denmark
Holbæk, , Denmark
Hvidovre, , Denmark
Silkeborg, , Denmark
Viborg, , Denmark
Tallinn, , Estonia
Tartu, , Estonia
Hyderabad, Andhra Pradesh, India
Secundrabad, Andhra Pradesh, India
Bangalore, Bangalore, India
Ludhiana, Punjab, India
Bangalore, , India
Mumbai, , India
Surabaya, Surabaya, Indonesia
Bandung, West Java, Indonesia
Genova, , Italy
Lecco, , Italy
Modena, , Italy
Napoli, , Italy
Parma, , Italy
Siena, , Italy
Udine, , Italy
Liepāja, , Latvia
Riga, , Latvia
Kaunas, , Lithuania
Klaipėda, , Lithuania
Panevezys, , Lithuania
Šiauliai, , Lithuania
Chihuahua, Chih., Chihuahua, Mexico
Guadalajara, Jalisco, Mexico
Auckland, , New Zealand
Auckland, , New Zealand
Kongsvinger, , Norway
Namsos, , Norway
Oslo, , Norway
Oslo, , Norway
Tynset, , Norway
Callao, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima Cercado, , Peru
Lisbon, Lisbon District, Portugal
Setúbal, Setúbal District, Portugal
Torres Vedras, Torres Vedras, Portugal
Porto, , Portugal
Bloemfontein, Freestate, South Africa
Johannesburg, Gauteng, South Africa
Randburg, Gauteng, South Africa
Newcastle, KwaZulu-Natal, South Africa
Cape Town, Western Cape, South Africa
Kyunggido, Kyunggido, South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Falköping, , Sweden
Hässleholm, , Sweden
Kungälv, , Sweden
Lidköping, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Varberg, , Sweden
Vaxjo, , Sweden
Kaohsiung City, , Taiwan
Taoyuan District, , Taiwan
Chesterfield, Derbyshire, United Kingdom
Dumfries, Dumfries and Galloway, United Kingdom
Kirkcaldy, Fife, United Kingdom
London, Greater London, United Kingdom
Liverpool, Merseyside, United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Northampton, Northamptonshire, United Kingdom
Epsom, Surrey, United Kingdom
Countries
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References
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Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2005-004691-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
11357
Identifier Type: -
Identifier Source: org_study_id
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