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 - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00332020

Purpose

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.

Condition	Intervention	Phase
Prevention Venous Thromboembolism	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	RECORD 2 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 Hip Replacement.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Rivaroxaban Enoxaparin Sodium

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 35+/-6 days ] [ Designated as safety issue: No ]
The composite endpoint comprising major VTE and treatment-emergent major bleeding [ Time Frame: 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 ] [ Designated as safety issue: No ]
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Treatment-emergent major bleedings [ Time Frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication ] [ Designated as safety issue: Yes ]

Enrollment:	2509
Study Start Date:	February 2006
Study Completion Date:	May 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Rivaroxaban (BAY59-7939) 10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
Arm 2: Active Comparator	Drug: Enoxaparin 40 mg enoxaparin syringe administered for 12 +/- 2 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332020

Hide Study Locations

Locations

United States, Alabama

Birmingham, Alabama, United States, 35205
United States, Colorado

Denver, Colorado, United States, 80222
United States, Florida

Bay Pines, Florida, United States, 33744

Miami, Florida, United States, 33186
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73103
Australia, Australian Capital Territory

Canberra, Australian Capital Territory, Australia, 2605
Australia, New South Wales

LISMORE, New South Wales, Australia, 2480

Sydney, New South Wales, Australia, 2065
Australia, Queensland

Southport, Queensland, Australia, 4215
Australia, Victoria

Geelong, Victoria, Australia, 3220

Melbourne, Victoria, Australia, 3128
Brazil

Rio de Janeiro, Brazil

Sao Paulo, Brazil, 0122-1020

Sao Paulo, Brazil, 04262-000
Brazil, Minas Gerais

Belo Horizonte, Minas Gerais, Brazil, 30380 090

Belo Horizonte, Minas Gerais, Brazil, 30170-132
Brazil, Paraná

Curitiba, Paraná, Brazil, 80050-350
Brazil, Rio Grande do Sul

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

Marília, Sao Paulo, Brazil, 17515-900

Batatais, Sao Paulo, Brazil, 14300 000
Brazil, SP

Sao Paulo, SP, Brazil, 04023-900
Canada, Alberta

Red Deer, Alberta, Canada, T4N 4E7
Canada, British Columbia

Penticton, British Columbia, Canada, V2A 5C8
Canada, Manitoba

Winnipeg, Manitoba, Canada, R3J 3M7
Canada, New Brunswick

St. John, New Brunswick, Canada, E2L 4L2
Canada, Ontario

Oshawa, Ontario, Canada, L1G 2B9

Ottawa, Ontario, Canada, K1H 8L6

Scarborough, Ontario, Canada, M1P 2V5

Windsor, Ontario, Canada, N9A 1E1

Thunder Bay, Ontario, Canada, P7B 6V4

Ottawa, Ontario, Canada, K1Y 4E9

Scarborough, Ontario, Canada, M1M 3W3
China

Beijing, China, 100853

Beijing, China, 100044

Beijing, China, 100035

Shanghai, China, 200433

Shanghai, China, 200025

Shanghai, China, 200032

Shanghai, China, 200233
China, Guangdong

Guangzhou,, Guangdong, China, 510405
China, Shangdong

Jinan, Shangdong, China, 250014

Qingdao, Shangdong, China, 266003
China, Shanxi

Xi'an, Shanxi, China, 710004
Colombia

Cali, Colombia

Medellín, Colombia

Bogotá, Colombia

Barranquilla, Colombia
Denmark

Holbaek, Denmark, 4300

Viborg, Denmark, 8800

Hvidovre, Denmark, 2650

Copenhagen, Denmark, 2300

Herlev, Denmark, 2730

Glostrup, Denmark, 2600

Silkeborg, Denmark, 8600

Copenhagen, Denmark, 2400

Frederiksberg, Denmark, 2000
Estonia

Tartu, Estonia, 51014

Tallinn, Estonia, 10138
India

Bangalore, India, 560001

Mumbai, India, 400012

Bangalore, India, 560034
India, Andhra Pradesh

Hyderabad, Andhra Pradesh, India, 500034
India, Andra Pradesh

Secundrabad, Andra Pradesh, India, 500003
India, Punjab

Ludhiana, Punjab, India, 141001
Indonesia

Surabaya, Indonesia
Indonesia, West Java

Bandung, West Java, Indonesia, 40161
Italy

Parma, Italy, 43100

Lecco, Italy, 23900

Udine, Italy, 33100

Siena, Italy, 53100

Modena, Italy, 41100

Genova, Italy, 16132

Napoli, Italy, 80131
Korea, Republic of

Seoul, Korea, Republic of, 135-710

Seoul, Korea, Republic of, 138-736

Daegu, Korea, Republic of, 700721

Kyunggido, Korea, Republic of, 471710
Latvia

Riga, Latvia

Liepaja, Latvia, 3402
Lithuania

Kaunas, Lithuania, 44320

Panevezys, Lithuania, 35144

Siauliai, Lithuania, 76231

Klaipeda, Lithuania, 92288
Mexico, Chihuahua

Chihuahua, Chih., Chihuahua, Mexico, 31000
Mexico, Jalisco

Guadalajara, Jalisco, Mexico, 44280
New Zealand

Auckland, New Zealand, 0622

Auckland, New Zealand, 1023
Norway

Tynset, Norway, 2501

Namsos, Norway, 7800

Oslo, Norway, 0264

Kongsvinger, Norway, 2212

Oslo, Norway, 0440
Peru

Callao, Peru, CALLAO 2

Lima, Peru, LIMA 1

Lima, Peru, LIMA 11

Lima, Peru, 31

Lima Cercado, Peru, LIMA 1

Lima, Peru, 01
Portugal

Porto, Portugal, 4200-319

Lisboa, Portugal, 1069-166

Setúbal, Portugal, 299-182

Torres Vedras, Portugal, 2560-324
South Africa, Freestate

Bloemfontein, Freestate, South Africa, 9300
South Africa, Gauteng

Johannesburg, Gauteng, South Africa, 2132

Randburg, Gauteng, South Africa, 2125
South Africa, Kwa Zulu-Natal

Newcastle, Kwa Zulu-Natal, South Africa, 2940
South Africa, Western Cape

Cape Town, Western Cape, South Africa, 7505
Sweden

Stockholm, Sweden, 112 81

Kungälv, Sweden, 442 83

Falköping, Sweden, 521 85

Örebro, Sweden, 701 85

Sundsvall, Sweden, 851 86

Växjö, Sweden, 351 85

Hässleholm, Sweden, 281 25

Lidköping, Sweden, 531 85

Varberg, Sweden, 432 81
Taiwan

Kaohsiung, Taiwan, 833

Taoyuan, Taiwan, 333
United Kingdom, Derbyshire

Chesterfield, Derbyshire, United Kingdom, S44 5BL
United Kingdom, Dumfries and Galloway

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

Kirkcaldy, Fife, United Kingdom, KY2 5AH
United Kingdom, Greater London

London, Greater London, United Kingdom, SE5 9RS
United Kingdom, Merseyside

Liverpool, Merseyside, United Kingdom, L14 3LB
United Kingdom, Norfolk

Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
United Kingdom, Northamptonshire

Northampton, Northamptonshire, United Kingdom, NN1 5BD
United Kingdom, Surrey

Epsom, Surrey, United Kingdom, KT18 7EG

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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. Epub 2008 Jun 24.

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11357, EudraCT: 2005-004691-20
Study First Received:	May 30, 2006
Last Updated:	January 19, 2009
ClinicalTrials.gov Identifier:	NCT00332020 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Venous Thromboembolism
Thromboembolism

Thrombosis
Pharmacologic Actions
Enoxaparin
Embolism and Thrombosis
Fibrin Modulating Agents
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 27, 2009