Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

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

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.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Rivaroxaban (BAY59-7939); Drug: Enoxaparin

• Study Type: Interventional
• Enrollment (Actual): 4541
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Avellaneda, Buenos Aires, Argentina, 1870
    • Berazategui, Buenos Aires, Argentina, 1884
  • Capital Federal
    • Buenos Aires, Capital Federal, Argentina, C1280AEB
    • Buenos Aires, Capital Federal, Argentina, 1426
    • Buenos Aires, Capital Federal, Argentina, C1039AAO
    • Buenos Aires, Capital Federal, Argentina, C1406FWY
    • Buenos Aires, Capital Federal, Argentina, C1425AGP
• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2217
  • South Australia
    • Adelaide, South Australia, Australia, 5042
  • Victoria
    • Melbourne, Victoria, Australia, 3128
    • Melbourne, Victoria, Australia, 3181
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
• Austria
  • Wien, Austria, 1140
  • Niederösterreich
    • Wiener Neustadt, Niederösterreich, Austria, 2700
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4010
    • Linz, Oberösterreich, Austria, 4020
    • Ried, Oberösterreich, Austria, 4910
    • Wels, Oberösterreich, Austria, 4600
  • Steiermark
    • Graz, Steiermark, Austria, 8036
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
• Belgium
  • Antwerpen, Belgium, 2020
  • Brasschaat, Belgium, 2930
  • Brugge, Belgium, 8000
  • Genk, Belgium, 3600
  • HUY, Belgium, 4500
  • Hasselt, Belgium, 3500
  • Merksem, Belgium, 2170
  • Pellenberg, Belgium, 3212
  • Reet, Belgium, 2840
  • Roeselare, Belgium, 8800
• Brazil
  • Rio de Janeiro, Brazil, 20 232 092
  • São Paulo, Brazil, 04039-004
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
    • Porto Alegre, RS, Brazil, 90470 340
• Canada
  • Quebec, Canada, G1L 3L5
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
    • Oakville, Ontario, Canada, L6J 3L7
    • Oshawa, Ontario, Canada, L1J 2J2
    • Peterborough, Ontario, Canada, K9J 7C6
    • Stratford, Ontario, Canada, N5A 2Y6
  • Quebec
    • Montreal, Quebec, Canada, H3T 1M5
    • Montreal, Quebec, Canada, H3G 1A4
• Chile
  • Santiago, Chile
• Colombia
  • Bogotá, Colombia
• Czech Republic
  • Ceske Budejovice, Czech Republic, 370 87
  • Hradec Kralove, Czech Republic, 500 05
  • Jindrichuv Hradec, Czech Republic, 377 38
  • Karlovy Vary, Czech Republic, 360 66
  • Mlada Boleslav, Czech Republic, 293 50
  • Olomouc, Czech Republic, 775 20
  • Plzen, Czech Republic, 304 60
  • Praha 6, Czech Republic, 169 02
  • Pribram I, Czech Republic, 261 26
  • Prostejov, Czech Republic, 796 04
• Denmark
  • Frederiksberg, Denmark, 2000
  • Hellerup, Denmark, 2900
  • Herlev, Denmark, 2730
  • Hørsholm, Denmark, DK-2970
  • Silkeborg, Denmark, 8600
• Finland
  • Jyväskylä, Finland, 40620
  • Mikkeli, Finland, FIN-50100
  • Seinäjoki, Finland, FIN 60220
• France
  • Bois-guillaume, France, 76230
  • Le Chesnay, France, 78150
  • Lievin, France, 62806
  • Monaco, France, 98000
  • Nantes Cedex 2, France, 44277
  • Paris, France, 75674
  • Paris Cedex 14, France, 75877
  • Paris Cedex 19, France, 75019
  • Paris Cedex 20, France, 75960
  • Saint Herblain, France, 44819
  • Soyaux, France, 16800
  • Vandoeuvre Les Nancy, France, 54511
  • Vannes, France, 56000
• Germany
  • Bremen, Germany, 28205
  • Baden-Württemberg
    • Bad Mergentheim, Baden-Württemberg, Germany, 97980
    • Heidelberg, Baden-Württemberg, Germany, 69112
    • Rheinfelden, Baden-Württemberg, Germany, 79618
    • Stuttgart, Baden-Württemberg, Germany, 70176
  • Bayern
    • Fürth, Bayern, Germany, 90766
    • Garmisch-Partenkirchen, Bayern, Germany, 82467
    • Würzburg, Bayern, Germany, 97080
  • Brandenburg
    • Birkenwerder, Brandenburg, Germany, 16547
    • Sommerfeld, Brandenburg, Germany, 16766
  • Hessen
    • Frankfurt, Hessen, Germany, 60528
    • Frankfurt, Hessen, Germany, 65929
    • Marburg, Hessen, Germany, 35043
    • Wiesbaden, Hessen, Germany, 65191
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18057
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
    • Witten, Nordrhein-Westfalen, Germany, 58448
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
• Greece
  • Attica
    • Haidari, Attica, Greece, 12462
    • Kifisia, Attica, Greece, 14561
• Hungary
  • Bekescsaba, Hungary, 5600
  • Budapest, Hungary, 1076
  • Budapest, Hungary, 1089
  • Györ, Hungary, 9024
  • Kaposvar, Hungary, 7400
  • Kecskemet, Hungary, 6000
  • Szeged, Hungary, 6725
  • Szekesfehervar, Hungary, 8000
  • Szekszard, Hungary, 7100
• Israel
  • Beer Sheva, Israel, 84101
  • Haifa, Israel, 31096
  • Holon, Israel, 58100
  • Kfar Saba, Israel, 44281
  • Petach Tikva, Israel, 49100
  • Tel Aviv, Israel, 64239
  • Tel Hashomer, Israel, 52621
  • Zerifin, Israel, 70300
• Italy
  • Ancona, Italy, 60126
  • Bergamo, Italy, 24128
  • Bologna, Italy, 40136
  • Ferrara, Italy, 44100
  • Firenze, Italy, 50139
  • Genova, Italy, 16132
  • Milano, Italy, 20162
  • Milano, Italy, 20132
  • Palermo, Italy, 90129
  • Reggio Emilia, Italy, 42100
  • Roma, Italy, 00168
  • Sassari, Italy, 07100
  • Torino, Italy, 10126
  • Varese, Italy, 21100
  • Milano
    • Monza, Milano, Italy, 20052
    • Rozzano, Milano, Italy, 20089
    • San Donato Milanese, Milano, Italy, 20097
  • Perugia
    • Gubbio, Perugia, Italy, 06024
  • Sassari
    • Alghero, Sassari, Italy, 07041
  • Varese
    • Busto Arsizio, Varese, Italy, 21052
• Lithuania
  • Kaunas, Lithuania, LT-50166
  • Vilnius, Lithuania, LT-04130
• Mexico
  • Edo. de Mexico, Mexico, 53120
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64380
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
  • Hilversum, Netherlands, 1213 XZ
  • Hoofddorp, Netherlands, 2134 TM
  • Leiden, Netherlands, 2334 CK
  • Nijmegen, Netherlands, 6522 JV
  • OSS, Netherlands, 5342 BT
  • Zwolle, Netherlands, 8011 JW
• Norway
  • Baerum postterminal, Norway, 1306
  • Elverum, Norway, 2409
  • Gjövik, Norway, 2819
  • Lillehammer, Norway, 2609
  • Notodden, Norway, NO-3675
• Poland
  • Bialystok, Poland, 15-276
  • Bydgoszcz, Poland, 85-681
  • Bydgoszcz, Poland, 85-094
  • Gdansk, Poland, 80-803
  • Katowice, Poland, 40-635
  • Krakow, Poland, 31-826
  • Krakow, Poland, 31-913
  • Krakow, Poland, 30-901
  • Lodz, Poland, 91-002
  • Lublin, Poland, 20-090
  • Lublin, Poland, 20-718
  • Opole, Poland, 45-060
  • Poznan, Poland, 60-703
  • Sosnowiec, Poland, 41-200
  • Szczecin, Poland, 71-252
  • Warszawa, Poland, 00-909
  • Warszawa, Poland, 03-242
  • Warszawa, Poland, 02-005
  • Wroclaw, Poland, 51-128
• Slovakia
  • Bratislava, Slovakia, 826 06
  • Kosice - Saca, Slovakia, 040 15
  • Zilina, Slovakia, 012 07
• South Africa
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0084
  • Western Cape
    • Somerset West, Western Cape, South Africa, 7130
    • Worcester, Western Cape, South Africa, 6850
• Spain
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08025
  • Barcelona, Spain, 08006
  • Castellón de la Plana, Spain, 12004
  • Jaén, Spain, 23007
  • Madrid, Spain, 28040
  • Pamplona, Spain, 31008
  • Valencia, Spain, 46010
  • Vitoria, Spain, 01009
  • A Coruña
    • Santiago de Compostela, A Coruña, Spain, 15706
  • Asturias
    • Oviedo, Asturias, Spain, 33006
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
    • L'Hospitalet de llobregat, Barcelona, Spain, 08906
  • Madrid
    • Alcorcón, Madrid, Spain, 28922
• Sweden
  • Göteborg, Sweden, 416 85
  • Halmstad, Sweden, 301 85
  • Jönköping, Sweden, 551 85
  • Lidköping, Sweden, 531 85
  • Varberg, Sweden, 432 81
  • Västervik, Sweden, 593 81
• Turkey
  • Adana, Turkey, 01330
  • Istanbul, Turkey, 34662
  • Istanbul, Turkey, 34722
  • Istanbul, Turkey, 34093
  • Izmir, Turkey, 35340
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
    • Northport, Alabama, United States, 35476
  • Arizona
    • Phoenix, Arizona, United States, 85023
  • Arkansas
    • Benton, Arkansas, United States, 72015
  • California
    • La Jolla, California, United States, 92037
  • Colorado
    • Aurora, Colorado, United States, 80012
  • Georgia
    • Decatur, Georgia, United States, 30033
  • Montana
    • Missoula, Montana, United States, 59802
  • South Carolina
    • Charleston, South Carolina, United States, 29414
  • Texas
    • Dallas, Texas, United States, 75231
    • Grapevine, Texas, United States, 76051
    • Lubbock, Texas, United States, 79410
    • San Antonio, Texas, United States, 78233

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 2	Drug: Enoxaparin; Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days
Experimental: Arm 1	Drug: Rivaroxaban (BAY59-7939); 10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes	Treatment period : up to day 36+/-6

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment-emergent major bleedings	From first dose of double-blind study medication to up to two days after last dose of double-blind study medication
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)	Treatment period : up to day 36+/-6
Incidence of symptomatic VTE (DVT, PE)	Treatment period : up to day 36+/-6
Incidence of DVT (total, proximal, distal)	Treatment period : up to day 36+/-6
Incidence of symptomatic VTE during follow-up	Follow-up period: following 36+/-6 days
The composite endpoint comprising major VTE and treatment-emergent major bleeding	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
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death	Treatment period : up to day 36+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death	Treatment period : up to day 36+/-6

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here and search for information of Bayer products for Europe

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: May 24, 2006
• First Submitted That Met QC Criteria: May 24, 2006
• First Posted (Estimate): May 25, 2006

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Prevention; Thromboembolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Enoxaparin
• Other Study ID Numbers: 11354 (DAIDS ES); EudraCT: 2005-004351-35