Back to resultsRegulation 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. (RECORD 3)
Primary Purpose
Prevention, Venous Thromboembolism
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivaroxaban (BAY59-7939)
Enoxaparin
Sponsored by
About this trial
This is an interventional prevention trial for Prevention
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 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
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
Secondary Outcome Measures
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Incidence of symptomatic VTE (DVT, PE)
Incidence of DVT (total, proximal, distal)
Incidence of symptomatic VTE during follow-up
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
Treatment-emergent major bleedings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00361894
Brief Title
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.
Acronym
RECORD 3
Official Title
RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-blind, Randomized Study of BAY 59-7939 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
February 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Bayer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention, Venous Thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2531 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban (BAY59-7939)
Intervention Description
10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
Primary Outcome Measure Information:
Title
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 13+/-4
Secondary Outcome Measure Information:
Title
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Time Frame
Treatment period: up to Day 13+/-4
Title
Incidence of symptomatic VTE (DVT, PE)
Time Frame
Treatment period: up to Day 13+/-4
Title
Incidence of DVT (total, proximal, distal)
Time Frame
Treatment period: up to Day 13+/-4
Title
Incidence of symptomatic VTE during follow-up
Time Frame
Follow-up period: following 13+/-4 days
Title
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time Frame
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
Title
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 13+/-4
Title
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 13+/-4
Title
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
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 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
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4010
Country
Austria
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
City
Wien
ZIP/Postal Code
1140
Country
Austria
City
Antwerpen
ZIP/Postal Code
2020
Country
Belgium
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
City
Liege
ZIP/Postal Code
4000
Country
Belgium
City
Merksem
ZIP/Postal Code
2170
Country
Belgium
City
Pellenberg
ZIP/Postal Code
3212
Country
Belgium
City
Reet
ZIP/Postal Code
2840
Country
Belgium
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7R 4C4
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2G 1G3
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
M1E 4B9
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
City
Beijing
ZIP/Postal Code
100035
Country
China
City
Beijing
ZIP/Postal Code
100044
Country
China
City
Beijing
ZIP/Postal Code
100853
Country
China
City
Shanghai
ZIP/Postal Code
200025
Country
China
City
Shanghai
ZIP/Postal Code
200032
Country
China
City
Shanghai
ZIP/Postal Code
200233
Country
China
City
Bogotá
Country
Colombia
City
Cali
Country
Colombia
City
Medellín
Country
Colombia
City
Praha 8
State/Province
Tschechien
ZIP/Postal Code
180 81
Country
Czech Republic
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
City
Chomutov
ZIP/Postal Code
430 01
Country
Czech Republic
City
Havlickuv Brod
ZIP/Postal Code
580 01
Country
Czech Republic
City
Jihlava
ZIP/Postal Code
586 01
Country
Czech Republic
City
Kolin
ZIP/Postal Code
280 00
Country
Czech Republic
City
Pardubice
ZIP/Postal Code
530 03
Country
Czech Republic
City
Plzen
ZIP/Postal Code
304 60
Country
Czech Republic
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Hørsholm
ZIP/Postal Code
DK-2970
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Bois-guillaume
ZIP/Postal Code
76230
Country
France
City
Clermont Ferrand
ZIP/Postal Code
63050
Country
France
City
Lievin
ZIP/Postal Code
62806
Country
France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Monaco
ZIP/Postal Code
98000
Country
France
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
City
Nice
ZIP/Postal Code
06000
Country
France
City
Nice
ZIP/Postal Code
06002
Country
France
City
Paris Cedex 14
ZIP/Postal Code
75877
Country
France
City
Paris Cedex 19
ZIP/Postal Code
75019
Country
France
City
Paris Cedex 20
ZIP/Postal Code
75960
Country
France
City
Paris
ZIP/Postal Code
75674
Country
France
City
Soyaux
ZIP/Postal Code
16800
Country
France
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
City
Bad Mergentheim
State/Province
Baden-Württemberg
ZIP/Postal Code
97980
Country
Germany
City
Rheinfelden
State/Province
Baden-Württemberg
ZIP/Postal Code
79618
Country
Germany
City
Fürth
State/Province
Bayern
ZIP/Postal Code
90766
Country
Germany
City
Garmisch-Partenkirchen
State/Province
Bayern
ZIP/Postal Code
82467
Country
Germany
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
City
Sommerfeld
State/Province
Brandenburg
ZIP/Postal Code
16766
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60528
Country
Germany
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
65929
Country
Germany
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
City
Witten
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
58448
Country
Germany
City
Bremen
ZIP/Postal Code
28205
Country
Germany
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Holon
ZIP/Postal Code
58100
Country
Israel
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
City
Abano Terme
State/Province
Padova
ZIP/Postal Code
35031
Country
Italy
City
Gubbio
State/Province
Perugia
ZIP/Postal Code
06024
Country
Italy
City
Alghero
State/Province
Sassari
ZIP/Postal Code
07041
Country
Italy
City
Bologna
ZIP/Postal Code
40136
Country
Italy
City
Firenze
ZIP/Postal Code
50139
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Padova
ZIP/Postal Code
35127
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Roma
ZIP/Postal Code
00168
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Varese
ZIP/Postal Code
21100
Country
Italy
City
Chihuahua, Chih.
State/Province
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
Country
Mexico
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
City
Hilversum
ZIP/Postal Code
1213 XZ
Country
Netherlands
City
Hoofddorp
ZIP/Postal Code
2134 TM
Country
Netherlands
City
Leiden
ZIP/Postal Code
2334 CK
Country
Netherlands
City
Nijmegen
ZIP/Postal Code
6522 JV
Country
Netherlands
City
OSS
ZIP/Postal Code
5342 BT
Country
Netherlands
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
City
Elverum
ZIP/Postal Code
2409
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
Namsos
ZIP/Postal Code
7800
Country
Norway
City
Callao
ZIP/Postal Code
CALLAO 2
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
City
Lodz
ZIP/Postal Code
91-002
Country
Poland
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Bloemfontein
State/Province
Freestate
ZIP/Postal Code
9300
Country
South Africa
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2132
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0084
Country
South Africa
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
PRETORIA
Country
South Africa
City
Pretoria
State/Province
Gauteng
Country
South Africa
City
Randburg
State/Province
Gauteng
ZIP/Postal Code
2125
Country
South Africa
City
Newcastle
State/Province
Kwa Zulu-Natal
ZIP/Postal Code
2940
Country
South Africa
City
Durban
State/Province
KwaZulu Natal
ZIP/Postal Code
4030
Country
South Africa
City
Somerset West
State/Province
Western Cape
ZIP/Postal Code
7130
Country
South Africa
City
Worcester
State/Province
Western Cape
ZIP/Postal Code
6850
Country
South Africa
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Castellón de la Plana
ZIP/Postal Code
12004
Country
Spain
City
Jaén
ZIP/Postal Code
23007
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Falköping
ZIP/Postal Code
521 85
Country
Sweden
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
City
Halmstad
ZIP/Postal Code
301 85
Country
Sweden
City
Hässleholm
ZIP/Postal Code
281 25
Country
Sweden
City
Jönköping
ZIP/Postal Code
551 85
Country
Sweden
City
Kungälv
ZIP/Postal Code
442 83
Country
Sweden
City
Lidköping
ZIP/Postal Code
531 85
Country
Sweden
City
Varberg
ZIP/Postal Code
432 81
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
18579812
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Learn more about this trial
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.
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