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

NCT00332020 | Completed Phase 3

• 2 other identifiers: 113572005-004691-20
• Study Type: interventional
• Target: 2,457
• Locations: 23 countries
• Sites: 126

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 can help prevent blood clots forming after a hip 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 35+/-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 35+/-6

• Incidence of symptomatic VTE (DVT, PE)

  Treatment period: up to day 35+/-6

• Incidence of DVT (total, proximal, distal)

  Treatment period: up to day 35+/-6

• Incidence of symptomatic VTE during follow-up

  Follow-up period: following 35+/-6 days

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

  For major VTE, treatment period: up to Day 35+/-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 rivaroxaban (tablet) once daily administered for 35 +/- 4 days

Arm 1

Enoxaparin DRUG

40 mg enoxaparin syringe administered for 12 +/- 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 (126)

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Birmingham, Alabama, 35205, United States

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Denver, Colorado, 80222, United States

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Bay Pines, Florida, 33744, United States

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Miami, Florida, 33186, United States

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Oklahoma City, Oklahoma, 73103, United States

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Canberra, Australian Capital Territory, 2605, Australia

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Lismore, New South Wales, 2480, Australia

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Sydney, New South Wales, 2065, Australia

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Southport, Queensland, 4215, Australia

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Geelong, Victoria, 3220, Australia

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Melbourne, Victoria, 3128, Australia

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Belo Horizonte, Minas Gerais, 30170-132, Brazil

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Belo Horizonte, Minas Gerais, 30380 090, Brazil

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Curitiba, Paraná, 80050-350, Brazil

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Passo Fundo, Rio Grande do Sul, 99010-100, Brazil

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Batatais, São Paulo, 14300 000, Brazil

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Marília, São Paulo, 17515-900, Brazil

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São Paulo, São Paulo, 0122-1020, Brazil

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São Paulo, São Paulo, 04023-900, Brazil

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São Paulo, São Paulo, 04262-000, Brazil

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Rio de Janeiro, Brazil

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Red Deer, Alberta, T4N 4E7, Canada

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Penticton, British Columbia, V2A 5C8, Canada

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Winnipeg, Manitoba, R3J 3M7, Canada

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Saint John, New Brunswick, E2L 4L2, Canada

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Oshawa, Ontario, L1G 2B9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Ottawa, Ontario, K1Y 4E9, Canada

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Scarborough Village, Ontario, M1M 3W3, Canada

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Scarborough Village, Ontario, M1P 2V5, Canada

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Thunder Bay, Ontario, P7B 6V4, Canada

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Windsor, Ontario, N9A 1E1, Canada

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Guangzhou, Guangdong, 510405, China

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Jinan, Shandong, 250014, China

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Qingdao, Shandong, 266003, China

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Xi’an, Shanxi, 710004, China

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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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Shanghai, 200433, China

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Barranquilla, Colombia

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Bogotá, Colombia

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Cali, Colombia

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Medellín, Colombia

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Copenhagen, 2300, Denmark

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Copenhagen, 2400, Denmark

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Frederiksberg, 2000, Denmark

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Glostrup Municipality, 2600, Denmark

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Herlev, 2730, Denmark

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Holbæk, 4300, Denmark

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Hvidovre, 2650, Denmark

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Silkeborg, 8600, Denmark

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Viborg, 8800, Denmark

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Tallinn, 10138, Estonia

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Tartu, 51014, Estonia

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Hyderabad, Andhra Pradesh, 500034, India

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Secundrabad, Andhra Pradesh, 500003, India

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Bangalore, Bangalore, 560034, India

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Ludhiana, Punjab, 141001, India

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Bangalore, 560001, India

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Mumbai, 400012, India

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Surabaya, Surabaya, Indonesia

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Bandung, West Java, 40161, Indonesia

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Genova, 16132, Italy

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Lecco, 23900, Italy

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Modena, 41100, Italy

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Napoli, 80131, Italy

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Parma, 43100, Italy

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Siena, 53100, Italy

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Udine, 33100, Italy

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Liepāja, 3402, Latvia

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Riga, Latvia

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Kaunas, 44320, Lithuania

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Klaipėda, 92288, Lithuania

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Panevezys, 35144, Lithuania

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Šiauliai, 76231, Lithuania

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Chihuahua, Chih., Chihuahua, 31000, Mexico

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Guadalajara, Jalisco, 44280, Mexico

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Auckland, 0622, New Zealand

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Auckland, 1023, New Zealand

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Kongsvinger, 2212, Norway

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Namsos, 7800, Norway

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Oslo, 0264, Norway

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Oslo, 0440, Norway

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Tynset, 2501, Norway

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Callao, CALLAO 2, Peru

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Lima, 01, Peru

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Lima, 31, Peru

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Lima, LIMA 11, Peru

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Lima, LIMA 1, Peru

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Lima Cercado, LIMA 1, Peru

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Lisbon, Lisbon District, 1069-166, Portugal

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Setúbal, Setúbal District, 299-182, Portugal

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Torres Vedras, Torres Vedras, 2560-324, Portugal

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Porto, 4200-319, Portugal

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Bloemfontein, Freestate, 9300, South Africa

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Johannesburg, Gauteng, 2132, South Africa

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Randburg, Gauteng, 2125, South Africa

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Newcastle, KwaZulu-Natal, 2940, South Africa

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Cape Town, Western Cape, 7505, South Africa

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Kyunggido, Kyunggido, 471710, South Korea

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Daegu, 700721, South Korea

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Seoul, 135-710, South Korea

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Seoul, 138-736, South Korea

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Falköping, 521 85, Sweden

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Hässleholm, 281 25, Sweden

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Kungälv, 442 83, Sweden

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Lidköping, 531 85, Sweden

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Örebro, 701 85, Sweden

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Stockholm, 112 81, Sweden

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Sundsvall, 851 86, Sweden

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Varberg, 432 81, Sweden

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Vaxjo, 351 85, Sweden

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Kaohsiung City, 833, Taiwan

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Taoyuan District, 333, Taiwan

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Chesterfield, Derbyshire, S44 5BL, United Kingdom

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Dumfries, Dumfries and Galloway, DG1 4EP, United Kingdom

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Kirkcaldy, Fife, KY2 5AH, United Kingdom

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London, Greater London, SE5 9RS, United Kingdom

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Liverpool, Merseyside, L14 3LB, United Kingdom

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Great Yarmouth, Norfolk, NR31 6LA, United Kingdom

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Northampton, Northamptonshire, NN1 5BD, United Kingdom

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Epsom, Surrey, KT18 7EG, United Kingdom

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Related Publications (1)

• 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.

  PMID: 18582928 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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: February 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 27, 2015

Record last verified: 2015-01

Locations

ES (2); SE (9); PT (4); ZA (5); IN (6); KR (4); TW (2); ME (2); NO (5); GB (8); LI (4); DK (9); AU (6); BR (10); CO (4); US (5); CA (11); ID (2); IT (7); NZ (2); LA (2); PE (6); CN (11)