Clinical trial NCT00329628: Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
Official title: RECORD 1 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: Prevention
Thromboembolism
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2006-05-25
Enrollment: 4541
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and prevent blood clot which may form after total hip replacement operation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 18 years or above
* Patients scheduled for elective total hip replacement

Exclusion Criteria:

* Planned, staged total bilateral hip replacement
* 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)

Primary outcomes:
measure: Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
timeFrame: Treatment period : up to day 36+/-6
Secondary outcomes:
measure: Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
timeFrame: Treatment period : up to day 36+/-6
measure: Incidence of symptomatic VTE (DVT, PE)
timeFrame: Treatment period : up to day 36+/-6
measure: Incidence of DVT (total, proximal, distal)
timeFrame: Treatment period : up to day 36+/-6
measure: Incidence of symptomatic VTE during follow-up
timeFrame: Follow-up period: following 36+/-6 days
measure: The composite endpoint comprising major VTE and treatment-emergent major bleeding
timeFrame: For major VTE, treatment period: up to Day 36+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication
measure: Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
timeFrame: Treatment period : up to day 36+/-6
measure: Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
timeFrame: Treatment period : up to day 36+/-6
measure: Treatment-emergent major bleedings
timeFrame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Benton
country: United States
state: Arkansas
city: La Jolla
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Decatur
country: United States
state: Georgia
city: Missoula
country: United States
state: Montana
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Grapevine
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Avellaneda
country: Argentina
state: Buenos Aires
city: Berazategui
country: Argentina
state: Buenos Aires
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Buenos Aires
country: Argentina
state: Capital Federal
city: Sydney
country: Australia
state: New South Wales
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Fremantle
country: Australia
state: Western Australia
city: Wiener Neustadt
country: Austria
state: Niederösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Linz
country: Austria
state: Oberösterreich
city: Ried
country: Austria
state: Oberösterreich
city: Wels
country: Austria
state: Oberösterreich
city: Graz
country: Austria
state: Steiermark
city: Innsbruck
country: Austria
state: Tirol
city: Wien
country: Austria
city: Antwerpen
country: Belgium
city: Brasschaat
country: Belgium
city: Brugge
country: Belgium
city: Genk
country: Belgium
city: Hasselt
country: Belgium
city: HUY
country: Belgium
city: Merksem
country: Belgium
city: Pellenberg
country: Belgium
city: Reet
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city: Roeselare
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city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Rio de Janeiro
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city: São Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Kitchener
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Peterborough
country: Canada
state: Ontario
city: Stratford
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
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state: Quebec
city: Quebec
country: Canada
city: Santiago
country: Chile
city: Bogotá
country: Colombia
city: Ceske Budejovice
country: Czech Republic
city: Hradec Kralove
country: Czech Republic
city: Jindrichuv Hradec
country: Czech Republic
city: Karlovy Vary
country: Czech Republic
city: Mlada Boleslav
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Plzen
country: Czech Republic
city: Praha 6
country: Czech Republic
city: Pribram I
country: Czech Republic
city: Prostejov
country: Czech Republic
city: Frederiksberg
country: Denmark
city: Hellerup
country: Denmark
city: Herlev
country: Denmark
city: Hørsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Jyväskylä
country: Finland
city: Mikkeli
country: Finland
city: Seinäjoki
country: Finland
city: Bois-guillaume
country: France
city: Le Chesnay
country: France
city: Lievin
country: France
city: Monaco
country: France
city: Nantes Cedex 2
country: France
city: Paris Cedex 14
country: France
city: Paris Cedex 19
country: France
city: Paris Cedex 20
country: France
city: Paris
country: France
city: Saint Herblain
country: France
city: Soyaux
country: France
city: Vandoeuvre Les Nancy
country: France
city: Vannes
country: France
city: Bad Mergentheim
country: Germany
state: Baden-Württemberg
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Rheinfelden
country: Germany
state: Baden-Württemberg
city: Stuttgart
country: Germany
state: Baden-Württemberg
city: Fürth
country: Germany
state: Bayern
city: Garmisch-Partenkirchen
country: Germany
state: Bayern
city: Würzburg
country: Germany
state: Bayern
city: Birkenwerder
country: Germany
state: Brandenburg
city: Sommerfeld
country: Germany
state: Brandenburg
city: Frankfurt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Wiesbaden
country: Germany
state: Hessen
city: Rostock
country: Germany
state: Mecklenburg-Vorpommern
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Witten
country: Germany
state: Nordrhein-Westfalen
city: Dresden
country: Germany
state: Sachsen
city: Bremen
country: Germany
city: Haidari
country: Greece
state: Attica
city: Kifisia
country: Greece
state: Attica
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Györ
country: Hungary
city: Kaposvar
country: Hungary
city: Kecskemet
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Beer Sheva
country: Israel
city: Haifa
country: Israel
city: Holon
country: Israel
city: Kfar Saba
country: Israel
city: Petach Tikva
country: Israel
city: Tel Aviv
country: Israel
city: Tel Hashomer
country: Israel
city: Zerifin
country: Israel
city: Monza
country: Italy
state: Milano
city: Rozzano
country: Italy
state: Milano
city: San Donato Milanese
country: Italy
state: Milano
city: Gubbio
country: Italy
state: Perugia
city: Alghero
country: Italy
state: Sassari
city: Busto Arsizio
country: Italy
state: Varese
city: Ancona
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Palermo
country: Italy
city: Reggio Emilia
country: Italy
city: Roma
country: Italy
city: Sassari
country: Italy
city: Torino
country: Italy
city: Varese
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Monterrey
country: Mexico
state: Nuevo Leon
city: Monterrey
country: Mexico
state: Nuevo León
city: Edo. de Mexico
country: Mexico
city: Amsterdam
country: Netherlands
city: Hilversum
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Leiden
country: Netherlands
city: Nijmegen
country: Netherlands
city: OSS
country: Netherlands
city: Zwolle
country: Netherlands
city: Baerum postterminal
country: Norway
city: Elverum
country: Norway
city: Gjövik
country: Norway
city: Lillehammer
country: Norway
city: Notodden
country: Norway
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bydgoszcz
country: Poland
city: Gdansk
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Opole
country: Poland
city: Poznan
country: Poland
city: Sosnowiec
country: Poland
city: Szczecin
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Bratislava
country: Slovakia
city: Kosice - Saca
country: Slovakia
city: Zilina
country: Slovakia
city: Pretoria
country: South Africa
state: Gauteng
city: Somerset West
country: South Africa
state: Western Cape
city: Worcester
country: South Africa
state: Western Cape
city: Santiago de Compostela
country: Spain
state: A Coruña
city: Oviedo
country: Spain
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: L'Hospitalet de llobregat
country: Spain
state: Barcelona
city: Alcorcón
country: Spain
state: Madrid
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Castellón de la Plana
country: Spain
city: Jaén
country: Spain
city: Madrid
country: Spain
city: Pamplona
country: Spain
city: Valencia
country: Spain
city: Vitoria
country: Spain
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Jönköping
country: Sweden
city: Lidköping
country: Sweden
city: Varberg
country: Sweden
city: Västervik
country: Sweden
city: Adana
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.