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

NCT00329628 | Completed Phase 3

• 2 other identifiers: 11354EudraCT: 2005-004351-35
• Study Type: interventional
• Target: 4,541
• Locations: 27 countries
• Sites: 210

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.

Conditions

Venous Thromboembolism

Keywords

Prevention; Thromboembolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Rivaroxaban (BAY59-7939)

Arm 2

ACTIVE COMPARATOR

Drug: Enoxaparin

Interventions

Rivaroxaban (BAY59-7939) DRUG

10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days

Arm 1

Enoxaparin DRUG

Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bayer: lead

Study Sites (215)

Unknown Facility

Birmingham, Alabama, 35205, United States

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Northport, Alabama, 35476, United States

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Phoenix, Arizona, 85023, United States

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Benton, Arkansas, 72015, United States

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La Jolla, California, 92037, United States

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Aurora, Colorado, 80012, United States

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Decatur, Georgia, 30033, United States

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Missoula, Montana, 59802, United States

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Charleston, South Carolina, 29414, United States

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Dallas, Texas, 75231, United States

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Grapevine, Texas, 76051, United States

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Lubbock, Texas, 79410, United States

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San Antonio, Texas, 78233, United States

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Avellaneda, Buenos Aires, 1870, Argentina

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Berazategui, Buenos Aires, 1884, Argentina

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Buenos Aires, Buenos Aires F.D., 1426, Argentina

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Buenos Aires, Buenos Aires F.D., C1039AAO, Argentina

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Buenos Aires, Buenos Aires F.D., C1280AEB, Argentina

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Buenos Aires, Buenos Aires F.D., C1406FWY, Argentina

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Buenos Aires, Buenos Aires F.D., C1425AGP, Argentina

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Sydney, New South Wales, 2217, Australia

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Adelaide, South Australia, 5042, Australia

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Melbourne, Victoria, 3128, Australia

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Melbourne, Victoria, 3181, Australia

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Fremantle, Western Australia, 6160, Australia

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Wiener Neustadt, Lower Austria, 2700, Austria

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Graz, Styria, 8036, Austria

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Innsbruck, Tyrol, 6020, Austria

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Linz, Upper Austria, 4010, Austria

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Linz, Upper Austria, 4020, Austria

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Ried, Upper Austria, 4910, Austria

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Wels, Upper Austria, 4600, Austria

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Vienna, Vienna, 1140, Austria

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Antwerp, 2020, Belgium

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Brasschaat, 2930, Belgium

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Bruges, 8000, Belgium

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Genk, 3600, Belgium

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Hasselt, 3500, Belgium

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Huy, 4500, Belgium

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Merksem, 2170, Belgium

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Pellenberg, 3212, Belgium

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Reet, 2840, Belgium

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Roeselare, 8800, Belgium

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Rio de Janeiro, Rio de Janeiro, 20 232 092, Brazil

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Porto Alegre, Rio Grande do Sul, 90470 340, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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São Paulo, São Paulo, 04039-004, Brazil

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Edmonton, Alberta, T6G 2B7, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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Oakville, Ontario, L6J 3L7, Canada

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Oshawa, Ontario, L1J 2J2, Canada

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Peterborough, Ontario, K9J 7C6, Canada

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Stratford, Ontario, N5A 2Y6, Canada

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Montreal, Quebec, H3G 1A4, Canada

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Montreal, Quebec, H3T 1M5, Canada

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Québec, Quebec, G1L 3L5, Canada

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Santiago, Chile

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Bogotá, Colombia

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České Budějovice, 370 87, Czechia

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Hradec Králové, 500 05, Czechia

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Jindřichův Hradec, 377 38, Czechia

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Karlovy Vary, 360 66, Czechia

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Mladá Boleslav, 293 50, Czechia

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Olomouc, 775 20, Czechia

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Pilsen, 304 60, Czechia

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Prague, 169 02, Czechia

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Pribram I, 261 26, Czechia

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Prostějov, 796 04, Czechia

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Frederiksberg, 2000, Denmark

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Hellerup, 2900, Denmark

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Herlev, 2730, Denmark

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Hørsholm, DK-2970, Denmark

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Silkeborg, 8600, Denmark

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Jyväskylä, 40620, Finland

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Mikkeli, FIN-50100, Finland

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Seinäjoki, FIN 60220, Finland

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Bois-Guillaume, 76230, France

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Le Chesnay, 78150, France

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Liévin, 62806, France

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Monaco, 98000, France

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Nantes, 44277, France

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Paris, 75019, France

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Paris, 75674, France

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Paris, 75877, France

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Paris, 75960, France

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Saint-Herblain, 44819, France

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Soyaux, 16800, France

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Vandœuvre-lès-Nancy, 54511, France

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Vannes, 56000, France

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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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Heidelberg, Baden-Wurttemberg, 69112, Germany

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Rheinfelden, Baden-Wurttemberg, 79618, Germany

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Stuttgart, Baden-Wurttemberg, 70176, Germany

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Fürth, Bavaria, 90766, Germany

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Garmisch-Partenkirchen, Bavaria, 82467, Germany

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Würzburg, Bavaria, 97080, Germany

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Birkenwerder, Brandenburg, 16547, Germany

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Sommerfeld, Brandenburg, 16766, Germany

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Bremen, City state Bremen, 28205, Germany

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Frankfurt am Main, Hesse, 60528, Germany

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Frankfurt am Main, Hesse, 65929, Germany

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Marburg, Hesse, 35043, Germany

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Wiesbaden, Hesse, 65191, Germany

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Rostock, Mecklenburg-Vorpommern, 18057, Germany

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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Witten, North Rhine-Westphalia, 58448, Germany

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Dresden, Saxony, 01307, Germany

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Haidari, Attica, 12462, Greece

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Kifissia, Attica, 14561, Greece

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Kaposvár, Hungary, 7400, Hungary

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Békéscsaba, 5600, Hungary

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Budapest, 1076, Hungary

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Budapest, 1089, Hungary

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Győr, 9024, Hungary

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Kecskemét, 6000, Hungary

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Szeged, 6725, Hungary

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Szekszárd, 7100, Hungary

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Székesfehérvár, 8000, Hungary

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Beersheba, Israel, 84101, Israel

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Haifa, Israel, 31096, Israel

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Holon, Israel, 58100, Israel

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Kfar Saba, Israel, 44281, Israel

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Petah Tikva, Israel, 49100, Israel

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Tel Aviv, Israel, 64239, Israel

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Ẕerifin, Israel, 70300, Israel

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Tel Litwinsky, 52621, Israel

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Monza, Milano, 20052, Italy

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Rozzano, Milano, 20089, Italy

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San Donato Milanese, Milano, 20097, Italy

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Gubbio, Perugia, 06024, Italy

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Alghero, Sassari, 07041, Italy

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Busto Arsizio, Varese, 21052, Italy

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Ancona, 60126, Italy

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Bergamo, 24128, Italy

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Bologna, 40136, Italy

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Ferrara, 44100, Italy

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Florence, 50139, Italy

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Genova, 16132, Italy

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Milan, 20132, Italy

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Milan, 20162, Italy

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Palermo, 90129, Italy

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Reggio Emilia, 42100, Italy

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Roma, 00168, Italy

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Sassari, 07100, Italy

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Torino, 10126, Italy

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Varese, 21100, Italy

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Kaunas, LT-50166, Lithuania

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Vilnius, LT-04130, Lithuania

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Monterrey, Nuevo León, 64380, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Edo. de Mexico, 53120, Mexico

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Amsterdam, 1105 AZ, Netherlands

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Hilversum, 1213 XZ, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Leiden, 2334 CK, Netherlands

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Nijmegen, 6522 JV, Netherlands

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Oss, 5342 BT, Netherlands

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Zwolle, 8011 JW, Netherlands

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Baerum Postterminal, 1306, Norway

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Elverum, 2409, Norway

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Gjøvik, 2819, Norway

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Lillehammer, 2609, Norway

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Notodden, NO-3675, Norway

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Bialystok, 15-276, Poland

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Bydgoszcz, 85-094, Poland

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Bydgoszcz, 85-681, Poland

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Gdansk, 80-803, Poland

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Katowice, 40-635, Poland

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Krakow, 30-901, Poland

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Krakow, 31-826, Poland

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Krakow, 31-913, Poland

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Lodz, 91-002, Poland

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Lublin, 20-090, Poland

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Lublin, 20-718, Poland

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Opole, 45-060, Poland

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Poznan, 60-703, Poland

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Sosnowiec, 41-200, Poland

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Szczecin, 71-252, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-005, Poland

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Warsaw, 03-242, Poland

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Wroclaw, 51-128, Poland

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Kosice - Saca, Slovakia, 040 15, Slovakia

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Bratislava, 826 06, Slovakia

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Žilina, 012 07, Slovakia

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Pretoria, Gauteng, 0084, South Africa

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Somerset West, Western Cape, 7130, South Africa

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Worcester, Western Cape, 6850, South Africa

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Santiago de Compostela, A Coruña, 15706, Spain

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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08006, Spain

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, Spain

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L'Hospitalet de Llobregat, Barcelona, 08906, Spain

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Castellon, Castellón de La Plana, 12004, Spain

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Jaén, Jaén, 23007, Spain

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Alcorcón, Madrid, 28922, Spain

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Madrid, Madrid, 28040, Spain

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Pamplona, Pamplona, 31008, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Valencia, Valencia, 46010, Spain

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Vitoria-Gasteiz, Vitoria, 01009, Spain

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Gothenburg, 416 85, Sweden

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Halmstad, 301 85, Sweden

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Jönköping, 551 85, Sweden

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Lidköping, 531 85, Sweden

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Varberg, 432 81, Sweden

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Västervik, 593 81, Sweden

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Adana, 01330, Turkey (Türkiye)

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Istanbul, 34093, Turkey (Türkiye)

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Istanbul, 34662, Turkey (Türkiye)

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Istanbul, 34722, Turkey (Türkiye)

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Izmir, 35340, Turkey (Türkiye)

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Related Publications (1)

• 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.

  PMID: 18579811 DERIVED

Related Links

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

MeSH Terms

Conditions

Venous Thromboembolism; Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: February 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

IT (20); PL (19); TU (5); CL (1); NO (5); NL (7); SL (3); ZA (3); US (13); DK (5); HU (9); AU (8); BR (4); CZ (10); CA (9); FI (3); IL (8); CO (1); ES (16); ME (3); FR (13); DE (18); GR (2); SE (6); BE (10); AR (7); LI (2)