Trial Condition(s):

Prevention, Venous Thromboembolism

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 (RECORD 2)

Bayer Identifier:

11357

ClinicalTrials.gov Identifier:

NCT00332020

EudraCT Number:

2005-004691-20

Study Completed

Trial 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.

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)

Trial Summary

Enrollment Goal
2457
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Kings College Hospital

London, United Kingdom, SE5 9RS

Status
Completed
 
Locations

Dumfries & Galloway Royal Infirmary

Dumfries, United Kingdom, DG1 4EP

Status
Completed
 
Locations

Chesterfield Royal Hospital

Chesterfield, United Kingdom, S44 5BL

Status
Completed
 
Locations

Oklahoma Thrombosis Research Group

Oklahoma City, United States, 73103

Status
Completed
 
Locations

Bay Pines VA Healthcare System

Bay Pines, United States, 33744

Status
Completed
 
Locations

Miami Institute for Medical Research

Miami, United States, 33186

Status
Completed
 
Locations

Capstone Clinical Trials, Inc.

Birmingham, United States, 35205

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Not yet recruiting
 
Locations

A.O. Ospedale di Lecco

Lecco, Italy, 23900

Status
Not yet recruiting
 
Locations

A.O.U. San Martino

Genova, Italy, 16132

Status
Not yet recruiting
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Red Deer Regional Hospital

Red Deer, Canada, T4N 4E7

Status
Completed
 
Locations

Hotel Dieu-Grace Hospital

Windsor, Canada, N9A 1E1

Status
Completed
 
Locations

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Canada, P7B 6V4

Status
Completed
 
Locations

Medical Arts Health Research Group

Penticton, Canada, V2A 5C8

Status
Completed
 
Locations

Victoria Hospital

Kirkcaldy, United Kingdom, KY2 5AH

Status
Completed
 
Locations

James Paget Hospital

Great Yarmouth, United Kingdom, NR31 6LA

Status
Completed
 
Locations

Epsom General Hospital

Epsom, United Kingdom, KT18 7EG

Status
Completed
 
Locations

Northampton General Hospital

Northampton, United Kingdom, NN1 5BD

Status
Completed
 
Locations

Broadgreen Hospital

Liverpool, United Kingdom, L14 3LB

Status
Completed
 
Locations

JCP Medical Research

Denver, United States, 80222

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41100

Status
Not yet recruiting
 
Locations

A.O.U. Santa Maria Misericordia UD

Udine, Italy, 33100

Status
Not yet recruiting
 
Locations

A.O.U. Senese

Siena, Italy, 53100

Status
Not yet recruiting
 
Locations

A.O.U. Federico II

Napoli, Italy, 80131

Status
Not yet recruiting
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

Ottawa Hospital - Civic Campus

Ottawa, Canada, K1Y 4E9

Status
Completed
 
Locations

St. John Regional Hospital

St. John, Canada, E2L 4L2

Status
Completed
 
Locations

Grace General Hospital

Winnipeg, Canada, R3J 3M7

Status
Completed
 
Locations

Scarbororgh Hospital-General Division

Scarborough, Canada, M1P 2V5

Status
Completed
 
Locations

Universitetssjukhuset

Örebro, Sweden, 701 85

Status
Completed
 
Locations

Kungälvs Sjukhus

Kungälv, Sweden, 442 83

Status
Completed
 
Locations

Skaraborgs Sjukhus Falköping

Falköping, Sweden, 521 85

Status
Completed
 
Locations

Capio S:t Görans Sjukhus AB

Stockholm, Sweden, 112 81

Status
Completed
 
Locations

Hässleholms Sjukhus

Hässleholm, Sweden, 281 25

Status
Completed
 
Locations

Sjukhuset i Varberg

Varberg, Sweden, 432 81

Status
Completed
 
Locations

Holbaek Sygehus

Holbaek, Denmark, 4300

Status
Completed
 
Locations

Viborg Sygehus

Viborg, Denmark, 8800

Status
Completed
 
Locations

Hvidovre Hospital

Hvidovre, Denmark, 2650

Status
Completed
 
Locations

H:S Bispebjerg Hospital

Copenhagen, Denmark, 2400

Status
Completed
 
Locations

Herlev Hospital

Herlev, Denmark, 2730

Status
Completed
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2132

Status
Completed
 
Locations

Olivedale Hospital

Randburg, South Africa, 2125

Status
Completed
 
Locations

University of Stellenbosch

Cape Town, South Africa, 7505

Status
Completed
 
Locations

Royal North Shore Hospital

Sydney, Australia, 2065

Status
Completed
 
Locations

Eastern Clinical Research Unit - Box Hill

Melbourne, Australia, 3128

Status
Completed
 
Locations

Hospital Curry Cabral

Lisboa, Portugal, 1069-166

Status
Completed
 
Locations

Scarbororgh Hospital-Grace Division

Scarborough, Canada, M1M 3W3

Status
Completed
 
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Status
Completed
 
Locations

Hospital Clínica del Parque

Chihuahua, Chih., Mexico, 31000

Status
Completed
 
Locations

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Växjö Centrallasarett

Växjö, Sweden, 351 85

Status
Completed
 
Locations

Skaraborgs Sjukhus Lidköping

Lidköping, Sweden, 531 85

Status
Completed
 
Locations

H:S Amager Hospital

Copenhagen, Denmark, 2300

Status
Completed
 
Locations

Amtssygehuset i Glostrup

Glostrup, Denmark, 2600

Status
Completed
 
Locations

Regionshospitalet Silkeborg

Silkeborg, Denmark, 8600

Status
Completed
 
Locations

H:S Frederiksberg Hospital

Frederiksberg, Denmark, 2000

Status
Completed
 
Locations

Sykehuset Innlandet HF Tynset

Tynset, Norway, 2501

Status
Completed
 
Locations

Helse Nord-Tönderlag HF sykehuset Namsos

Namsos, Norway, 7800

Status
Completed
 
Locations

Omnia Røde Kors Klinikk AS

Oslo, Norway, 0264

Status
Completed
 
Locations

Sykehuset Innlandet HF Kongsvinger

Kongsvinger, Norway, 2212

Status
Completed
 
Locations

Lovisenberg Diakonale sykehus

Oslo, Norway, 0440

Status
Completed
 
Locations

Private Practice Dr UK Dhanjee

Newcastle, South Africa, 2940

Status
Completed
 
Locations

University of the Free State

Bloemfontein, South Africa, 9300

Status
Completed
 
Locations

The Canberra Hospital

Canberra, Australia, 2605

Status
Completed
 
Locations

Lismore Base Hospital

LISMORE, Australia, 2480

Status
Completed
 
Locations

Gold Coast Hospital

Southport, Australia, 4215

Status
Completed
 
Locations

Geelong Hospital

Geelong, Australia, 3220

Status
Completed
 
Locations

H.Sant¿lago do Outão

Setúbal, Portugal, 299-182

Status
Completed
 
Locations

Centro Hospitalar de Torres Vedras

Torres Vedras, Portugal, 2560-324

Status
Completed
 
Locations

Hospital de São João

Porto, Portugal, 4200-319

Status
Completed
 
Locations

Hospital Universitario de la Samaritana

Bogotá, Colombia

Status
Completed
 
Locations

Centro Médico Imbanaco

Cali, Colombia

Status
Completed
 
Locations

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Brazil

Status
Completed
 
Locations

Hospital Madre Tereza

Belo Horizonte, Brazil, 30380 090

Status
Completed
 
Locations

CE Serv. Cirurg. e Reabilitação Ortopédico-Traumalogica

Batatais, Brazil, 14300 000

Status
Completed
 
Locations

Hospital Universitário Cajuru da PUC PR

Curitiba, Brazil, 80050-350

Status
Completed
 
Locations

Hospital Ipiranga

Sao Paulo, Brazil, 04262-000

Status
Completed
 
Locations

PS Fraturas Centro de Estudos Ortopédicos de Passo Fundo

Passo Fundo, Brazil, 99010-100

Status
Completed
 
Locations

General Hospital of People's Libration Army

Beijing, China, 100853

Status
Completed
 
Locations

Peking University Jishuitan Hospital

Beijing, China, 100035

Status
Completed
 
Locations

Jinan Qianfoshan Hospital

Jinan, China, 250014

Status
Completed
 
Locations

Changhai Hospital of Second Military Medical University

Shanghai, China, 200433

Status
Completed
 
Locations

Dr Soetomo Hospital

Surabaya, Indonesia

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Hanyang University Guri Hospital

Kyunggido, South Korea, 471710

Status
Completed
 
Locations

Siauliai County Hospital

Siauliai, Lithuania, 76231

Status
Completed
 
Locations

Klaipeda University Hospital

Klaipeda, Lithuania, 92288

Status
Completed
 
Locations

Tartu University Hospital

Tartu, Estonia, 51014

Status
Completed
 
Locations

Hospital Guillermo Almenara

Lima, Peru, LIMA 1

Status
Completed
 
Locations

Hospital Edgardo Rebagliati Martins

Lima, Peru, LIMA 11

Status
Completed
 
Locations

Centro Médico Naval

Callao, Peru, CALLAO 2

Status
Completed
 
Locations

Hospital Dos de Mayo

Lima, Peru, 01

Status
Completed
 
Locations

Horpital of Traumathology and Orthopedics

Riga, Latvia

Status
Completed
 
Locations

Riga 2nd City Hospital

Riga, Latvia

Status
Completed
 
Locations

Central Hospital of Liepaja

Liepaja, Latvia, 3402

Status
Completed
 
Locations

Fundacio del Caribe para la Investigacio Bio-Medica (BIOS)

Barranquilla, Colombia

Status
Completed
 
Locations

Clínica Medellín

Medellín, Colombia

Status
Completed
 
Locations

Centro de Investigación Clínica FOQUS

Bogotá, Colombia

Status
Completed
 
Locations

Inst. de Previdência do Servidor do Estado de Minas Gerais

Belo Horizonte, Brazil, 30170-132

Status
Completed
 
Locations

Irmandade da Santa Casa de Misericordia - Sao Paulo

Sao Paulo, Brazil, 0122-1020

Status
Completed
 
Locations

Irmandade Santa Casa de Misericórdia de Marília

Marília, Brazil, 17515-900

Status
Completed
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-900

Status
Completed
 
Locations

Peking University People's Hospital

Beijing, China, 100044

Status
Completed
 
Locations

The 6th People's Hospital of Shanghai Jiao Tong University

Shanghai, China, 200233

Status
Completed
 
Locations

Rui Jin Hospital, Shanghai Second Medical University

Shanghai, China, 200025

Status
Completed
 
Locations

Zhongshan Hospital Fudan University.

Shanghai, China, 200032

Status
Completed
 
Locations

The affili. hospital of medical college Qingdao University

Qingdao, China, 266003

Status
Completed
 
Locations

First Affiliated Hospital of Guangzhou University of TCM

Guangzhou,, China, 510405

Status
Completed
 
Locations

Second Affiliated Hospital Xian Jiaotong University School

Xi'an, China, 710004

Status
Completed
 
Locations

Dr Hasan Sadikin Hospital

Bandung, Indonesia, 40161

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Kyungpook National University Hospital

Daegu, South Korea, 700721

Status
Completed
 
Locations

Kaunas Red Cross Clinical Hospital

Kaunas, Lithuania, 44320

Status
Completed
 
Locations

Panevezys Hospital

Panevezys, Lithuania, 35144

Status
Completed
 
Locations

Dayanand Medical College& Hospital

Ludhiana, India, 141001

Status
Completed
 
Locations

St John's Medical College Hospital

Bangalore, India, 560034

Status
Completed
 
Locations

CARE Hospital

Hyderabad, India, 500034

Status
Completed
 
Locations

Yashodha Hospital

Secundrabad, India, 500003

Status
Completed
 
Locations

Victoria Hospital

Bangalore, India, 560001

Status
Completed
 
Locations

KEM hospital

Mumbai, India, 400012

Status
Completed
 
Locations

Chang Gung Memorial Hospital Kaohsiung

Kaohsiung, Taiwan, China, 833

Status
Not yet recruiting
 
Locations

Chang-Guang Memorial Hospital

Taoyuan, Taiwan, China, 333

Status
Not yet recruiting
 
Locations

East Tallinn Central Hospital

Tallinn, Estonia, 10138

Status
Completed
 
Locations

Hospital Alberto Sabogal

Callao, Peru, CALLAO 2

Status
Completed
 
Locations

Hospital Nacional Cayetano Heredia

Lima, Peru, 31

Status
Completed
 
Locations

Hospital Nacional Arzobispo Loayza

Lima Cercado, Peru, LIMA 1

Status
Completed
 
Locations

North Shore Hospital

Auckland, New Zealand, 0622

Status
Completed
 
Locations

Thrombosis Unit

Auckland, New Zealand, 1023

Status
Completed
 

Trial Design