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Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement. (RECORD 4)

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban (Xarelto, BAY59-7939)
Enoxaparin
Placebo: tablet of Rivaroxaban
Placebo: syringes of Enoxaparin
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring Prevention of venous thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female patients aged 18 years or above Patients scheduled for elective total knee replacement Exclusion Criteria: Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH) Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country) Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

Enoxaparin 30 mg twice a day (bid)

Arm Description

Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.

Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Outcomes

Primary Outcome Measures

Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

Secondary Outcome Measures

Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of DVT (Proximal, Distal) Per Protocol Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of Symptomatic VTE During Follow-up Per Protocol Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions
Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Treatment-emergent Major Bleedings Per Safety Population.
Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)

Full Information

First Posted
August 8, 2006
Last Updated
October 28, 2014
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT00362232
Brief Title
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
Acronym
RECORD 4
Official Title
RECORD 4 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled, Double-blind, Randomized Study of BAY59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bayer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Prevention of venous thromboembolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3148 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))
Arm Type
Experimental
Arm Description
Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
Arm Title
Enoxaparin 30 mg twice a day (bid)
Arm Type
Active Comparator
Arm Description
Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (Xarelto, BAY59-7939)
Intervention Description
Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
Intervention Type
Drug
Intervention Name(s)
Placebo: tablet of Rivaroxaban
Intervention Description
Placebo tablet of rivaroxaban administered once daily in the evening.
Intervention Type
Drug
Intervention Name(s)
Placebo: syringes of Enoxaparin
Intervention Description
Placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
Primary Outcome Measure Information:
Title
Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Secondary Outcome Measure Information:
Title
Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of DVT (Proximal, Distal) Per Protocol Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of Symptomatic VTE During Follow-up Per Protocol Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 47 days after surgery
Title
Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 47 days after surgery
Title
The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography, anesthesia and surgery reports, number of transfusions
Time Frame
Up to 47 days after surgery
Title
Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.
Description
Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography
Time Frame
Up to 16 days after surgery
Title
Treatment-emergent Major Bleedings Per Safety Population.
Description
Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)
Time Frame
from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients aged 18 years or above Patients scheduled for elective total knee replacement Exclusion Criteria: Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH) Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country) Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90502-2004
Country
United States
City
Yuba City
State/Province
California
ZIP/Postal Code
95991
Country
United States
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472-2952
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73162
Country
United States
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78205
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 6V7
Country
Canada
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 4V5
Country
Canada
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5N5
Country
Canada
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J4
Country
Canada
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 1G9
Country
Canada
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 3M5
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 7C6
Country
Canada
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1M 3W3
Country
Canada
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1Y8
Country
Canada
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
City
Woodstock
State/Province
Ontario
ZIP/Postal Code
N4S 5B2
Country
Canada
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 8T5
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
City
Hørsholm
ZIP/Postal Code
2970
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500004
Country
India
City
Secunderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500 003
Country
India
City
Secundrabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500003
Country
India
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380054
Country
India
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411009
Country
India
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600 006
Country
India
City
Bangalore
ZIP/Postal Code
560001
Country
India
City
Bangalore
ZIP/Postal Code
560034
Country
India
City
Baroda
ZIP/Postal Code
390007
Country
India
City
Hyderabad
Country
India
City
New Delhi
ZIP/Postal Code
110029
Country
India
City
Beer Sheva
ZIP/Postal Code
85025
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
City
Kaunas
ZIP/Postal Code
44320
Country
Lithuania
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Panevezys
ZIP/Postal Code
35144
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44200
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44350
Country
Mexico
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45100
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64000
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64380
Country
Mexico
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97150
Country
Mexico
City
Edo. de Mexico
ZIP/Postal Code
53120
Country
Mexico
City
Baerum postterminal
ZIP/Postal Code
1306
Country
Norway
City
Gjövik
ZIP/Postal Code
2819
Country
Norway
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
City
Lillehammer
ZIP/Postal Code
2609
Country
Norway
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74800
Country
Pakistan
City
Karachi
State/Province
Sindh
Country
Pakistan
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
City
Kielce
Country
Poland
City
Konskie
ZIP/Postal Code
26-200
Country
Poland
City
Krakow
ZIP/Postal Code
31-913
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Sosnowiec
ZIP/Postal Code
41-200
Country
Poland
City
Warszawa
ZIP/Postal Code
02-005
Country
Poland
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
City
Colombo-80
Country
Sri Lanka
City
Kotte
Country
Sri Lanka
City
Ragama
Country
Sri Lanka
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Hässleholm
ZIP/Postal Code
281 25
Country
Sweden
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
City
Västervik
ZIP/Postal Code
593 81
Country
Sweden
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19411100
Citation
Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4. Erratum In: Lancet. 2022 Dec 10;400(10368):2048.
Results Reference
result
Links:
URL
http://www.clinicaltrialsregister.eu
Description
Click here and search for information of Bayer products for Europe

Learn more about this trial

Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.

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