Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE). A Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

NCT00361894 | Completed Phase 3

• 2 other identifiers: 11356EudraCT: 2005-004620-40
• Study Type: interventional
• Target: 2,531
• Locations: 19 countries
• Sites: 143

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 prevents blood clot which may form after a knee replacement operation.

Conditions

Prevention; Venous 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 13+/-4

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 13+/-4

• Incidence of symptomatic VTE (DVT, PE)

  Treatment period: up to Day 13+/-4

• Incidence of DVT (total, proximal, distal)

  Treatment period: up to Day 13+/-4

• Incidence of symptomatic VTE during follow-up

  Follow-up period: following 13+/-4 days

• The composite endpoint comprising major VTE and treatment-emergent major bleeding

  For major VTE, treatment period: up to Day 13+/-4 ; 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 rivaroxaban (tablet) once daily administered for 13 +/- 2 days

Arm 1

Enoxaparin DRUG

Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Arm 2

Eligibility Criteria

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (143)

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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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Vienna, Vienna, 1140, Austria

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Antwerp, 2020, Belgium

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Hasselt, 3500, Belgium

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Liège, 4000, 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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Penticton, British Columbia, V2A 5C8, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Burlington, Ontario, L7R 4C4, Canada

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Kitchener, Ontario, N2G 1G3, Canada

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Oakville, Ontario, L6J 3M5, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Peterborough, Ontario, K9J 7C6, Canada

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Scarborough Village, Ontario, M1E 4B9, Canada

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Windsor, Ontario, N9A 1E1, Canada

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Beijing, 100035, China

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Beijing, 100044, China

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Beijing, 100853, China

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Shanghai, 200025, China

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Shanghai, 200032, China

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Shanghai, 200233, China

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Bogotá, Colombia

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Cali, Colombia

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Medellín, Colombia

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Prague, Tschechien, 180 81, Czechia

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Brno, 62500, Czechia

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Chomutov, 430 01, Czechia

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Havlíčkův Brod, 580 01, Czechia

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Jihlava, 586 01, Czechia

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Kolín, 280 00, Czechia

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Pardubice, 530 03, Czechia

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Pilsen, 304 60, 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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Bois-Guillaume, 76230, France

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Clermont-Ferrand, 63050, France

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Liévin, 62806, France

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Marseille, 13008, France

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Monaco, 98000, France

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Nantes, 44277, France

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Nice, 06000, France

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Nice, 06002, 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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Soyaux, 16800, France

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Vandœuvre-lès-Nancy, 54511, France

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Bad Mergentheim, Baden-Wurttemberg, 97980, Germany

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Rheinfelden, Baden-Wurttemberg, 79618, 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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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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Düsseldorf, North Rhine-Westphalia, 40225, Germany

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Witten, North Rhine-Westphalia, 58448, Germany

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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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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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San Donato Milanese, Milano, 20097, Italy

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Abano Terme, Padova, 35031, Italy

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Gubbio, Perugia, 06024, Italy

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Alghero, Sassari, 07041, Italy

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Bologna, 40136, Italy

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Florence, 50139, Italy

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Lecco, 23900, Italy

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Padua, 35127, Italy

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Parma, 43100, Italy

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Roma, 00168, Italy

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Udine, 33100, Italy

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Varese, 21100, Italy

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Chihuahua, Chih., Chihuahua, 31000, Mexico

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Guadalajara, Jalisco, 44280, Mexico

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Hermosillo, Sonora, 83000, 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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Elverum, 2409, Norway

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Gjøvik, 2819, Norway

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Kongsvinger, 2212, Norway

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Lillehammer, 2609, Norway

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Namsos, 7800, Norway

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Callao, CALLAO 2, Peru

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Lima, LIMA 11, Peru

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Lima, LIMA 1, Peru

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Bialystok, 15-276, Poland

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Bydgoszcz, 85-094, Poland

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Gdansk, 80-803, Poland

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Krakow, 31-826, 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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Szczecin, 71-252, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-637, Poland

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Bloemfontein, Freestate, 9300, South Africa

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Johannesburg, Gauteng, 2132, South Africa

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Pretoria, Gauteng, 0084, South Africa

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Pretoria, Gauteng, PRETORIA, South Africa

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Pretoria, Gauteng, South Africa

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Randburg, Gauteng, 2125, South Africa

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Durban, KwaZulu-Natal, 4030, South Africa

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Newcastle, KwaZulu-Natal, 2940, 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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Badalona, Barcelona, 08916, Spain

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Barcelona, Barcelona, 08006, Spain

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Barcelona, Barcelona, 08035, Spain

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Barcelona, Barcelona, 08036, 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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Valencia, Valencia, 46010, Spain

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Falköping, 521 85, Sweden

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Gothenburg, 416 85, Sweden

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Halmstad, 301 85, Sweden

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Hässleholm, 281 25, Sweden

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Jönköping, 551 85, Sweden

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Kungälv, 442 83, Sweden

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Lidköping, 531 85, Sweden

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Varberg, 432 81, Sweden

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Related Publications (1)

• Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.

  PMID: 18579812 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; 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: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 9, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

DE (11); IL (7); ES (10); CA (10); PL (10); PE (3); AU (4); FR (14); DK (5); SE (8); NL (7); BE (7); CZ (8); ME (3); IT (12); NO (5); CN (6); ZA (10); CO (3)