Back to resultsRegulation 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)
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 treatment trial for Prevention
Eligibility 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)
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
NCT00332020
Brief Title
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
Acronym
RECORD 2
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 can help prevent blood clots forming after a hip 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
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2457 (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 35 +/- 4 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
40 mg enoxaparin syringe administered for 12 +/- 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 35+/-6
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 35+/-6
Title
Incidence of symptomatic VTE (DVT, PE)
Time Frame
Treatment period: up to day 35+/-6
Title
Incidence of DVT (total, proximal, distal)
Time Frame
Treatment period: up to day 35+/-6
Title
Incidence of symptomatic VTE during follow-up
Time Frame
Follow-up period: following 35+/-6 days
Title
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
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 35+/-6
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 35+/-6
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 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)
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
35205
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80222
Country
United States
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30170-132
Country
Brazil
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30380 090
Country
Brazil
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80050-350
Country
Brazil
City
Passo Fundo
State/Province
Rio Grande do Sul
ZIP/Postal Code
99010-100
Country
Brazil
City
Batatais
State/Province
Sao Paulo
ZIP/Postal Code
14300 000
Country
Brazil
City
Marília
State/Province
Sao Paulo
ZIP/Postal Code
17515-900
Country
Brazil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-900
Country
Brazil
City
Rio de Janeiro
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
0122-1020
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04262-000
Country
Brazil
City
Red Deer
State/Province
Alberta
ZIP/Postal Code
T4N 4E7
Country
Canada
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5C8
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 3M7
Country
Canada
City
St. John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
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
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7B 6V4
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1E1
Country
Canada
City
Guangzhou,
State/Province
Guangdong
ZIP/Postal Code
510405
Country
China
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266003
Country
China
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710004
Country
China
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
Shanghai
ZIP/Postal Code
200433
Country
China
City
Barranquilla
Country
Colombia
City
Bogotá
Country
Colombia
City
Cali
Country
Colombia
City
Medellín
Country
Colombia
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Holbaek
ZIP/Postal Code
4300
Country
Denmark
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Viborg
ZIP/Postal Code
8800
Country
Denmark
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
City
Secundrabad
State/Province
Andra Pradesh
ZIP/Postal Code
500003
Country
India
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141001
Country
India
City
Bangalore
ZIP/Postal Code
560001
Country
India
City
Bangalore
ZIP/Postal Code
560034
Country
India
City
Mumbai
ZIP/Postal Code
400012
Country
India
City
Bandung
State/Province
West Java
ZIP/Postal Code
40161
Country
Indonesia
City
Surabaya
Country
Indonesia
City
Genova
ZIP/Postal Code
16132
Country
Italy
City
Lecco
ZIP/Postal Code
23900
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Daegu
ZIP/Postal Code
700721
Country
Korea, Republic of
City
Kyunggido
ZIP/Postal Code
471710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
City
Liepaja
ZIP/Postal Code
3402
Country
Latvia
City
Riga
Country
Latvia
City
Kaunas
ZIP/Postal Code
44320
Country
Lithuania
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
City
Panevezys
ZIP/Postal Code
35144
Country
Lithuania
City
Siauliai
ZIP/Postal Code
76231
Country
Lithuania
City
Chihuahua, Chih.
State/Province
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
City
Auckland
ZIP/Postal Code
0622
Country
New Zealand
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
City
Kongsvinger
ZIP/Postal Code
2212
Country
Norway
City
Namsos
ZIP/Postal Code
7800
Country
Norway
City
Oslo
ZIP/Postal Code
0264
Country
Norway
City
Oslo
ZIP/Postal Code
0440
Country
Norway
City
Tynset
ZIP/Postal Code
2501
Country
Norway
City
Callao
ZIP/Postal Code
CALLAO 2
Country
Peru
City
Lima Cercado
ZIP/Postal Code
LIMA 1
Country
Peru
City
Lima
ZIP/Postal Code
01
Country
Peru
City
Lima
ZIP/Postal Code
31
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
City
Lisboa
ZIP/Postal Code
1069-166
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Setúbal
ZIP/Postal Code
299-182
Country
Portugal
City
Torres Vedras
ZIP/Postal Code
2560-324
Country
Portugal
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
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
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7505
Country
South Africa
City
Falköping
ZIP/Postal Code
521 85
Country
Sweden
City
Hässleholm
ZIP/Postal Code
281 25
Country
Sweden
City
Kungälv
ZIP/Postal Code
442 83
Country
Sweden
City
Lidköping
ZIP/Postal Code
531 85
Country
Sweden
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
City
Sundsvall
ZIP/Postal Code
851 86
Country
Sweden
City
Varberg
ZIP/Postal Code
432 81
Country
Sweden
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S44 5BL
Country
United Kingdom
City
Dumfries
State/Province
Dumfries and Galloway
ZIP/Postal Code
DG1 4EP
Country
United Kingdom
City
Kirkcaldy
State/Province
Fife
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L14 3LB
Country
United Kingdom
City
Great Yarmouth
State/Province
Norfolk
ZIP/Postal Code
NR31 6LA
Country
United Kingdom
City
Northampton
State/Province
Northamptonshire
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
City
Epsom
State/Province
Surrey
ZIP/Postal Code
KT18 7EG
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
18582928
Citation
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.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu/
Description
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Learn more about this trial
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
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