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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00332020




Registration number
NCT00332020
Ethics application status
Date submitted
30/05/2006
Date registered
31/05/2006
Date last updated
27/01/2015

Titles & IDs
Public 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
Scientific 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.
Secondary ID [1] 0 0
2005-004691-20
Secondary ID [2] 0 0
11357
Universal Trial Number (UTN)
Trial acronym
RECORD 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention 0 0
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (BAY59-7939)
Treatment: Drugs - Enoxaparin

Experimental: Arm 1 -

Active Comparator: Arm 2 -


Treatment: Drugs: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

Treatment: Drugs: Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes
Timepoint [1] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [1] 0 0
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)
Timepoint [1] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [2] 0 0
Incidence of symptomatic VTE (DVT, PE)
Timepoint [2] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [3] 0 0
Incidence of DVT (total, proximal, distal)
Timepoint [3] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [4] 0 0
Incidence of symptomatic VTE during follow-up
Timepoint [4] 0 0
Follow-up period: following 35+/-6 days
Secondary outcome [5] 0 0
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Timepoint [6] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [7] 0 0
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death
Timepoint [7] 0 0
Treatment period: up to day 35+/-6
Secondary outcome [8] 0 0
Treatment-emergent major bleedings
Timepoint [8] 0 0
From first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Eligibility
Key inclusion criteria
- Male and female patients aged 18 years or above

- Patients scheduled for elective total hip replacement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2007
Sample size
Target
Accrual to date
Final
2457
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Canberra
Recruitment hospital [2] 0 0
- Lismore
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Southport
Recruitment hospital [5] 0 0
- Geelong
Recruitment hospital [6] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
4215 - Southport
Recruitment postcode(s) [5] 0 0
3220 - Geelong
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Oklahoma
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Brazil
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Minas Gerais
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Brazil
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Paraná
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Brazil
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Rio Grande do Sul
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Brazil
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Sao Paulo
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Brazil
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SP
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Brazil
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Rio de Janeiro
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Manitoba
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Canada
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New Brunswick
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Canada
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Ontario
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China
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Guangdong
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China
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Shandong
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China
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Shanxi
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China
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Beijing
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China
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Shanghai
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Colombia
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Barranquilla
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Colombia
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Bogotá
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Colombia
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Cali
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Colombia
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Medellín
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Denmark
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Copenhagen
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Frederiksberg
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Glostrup
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Herlev
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Holbaek
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Hvidovre
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Silkeborg
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Denmark
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Viborg
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Estonia
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Tallinn
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Estonia
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Tartu
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India
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Andhra Pradesh
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India
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Andra Pradesh
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India
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Punjab
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India
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Bangalore
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India
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Mumbai
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Indonesia
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West Java
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Indonesia
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Surabaya
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Italy
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Genova
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Italy
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Lecco
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Italy
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Modena
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Italy
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Napoli
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Italy
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Parma
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Italy
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Siena
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Italy
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Udine
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Korea, Republic of
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Klaipeda
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Panevezys
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Jalisco
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Auckland
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Kongsvinger
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Norway
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Namsos
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Norway
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Oslo
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Norway
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Tynset
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Peru
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Callao
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Peru
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Lima Cercado
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Peru
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Lima
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Setúbal
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Portugal
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Torres Vedras
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Freestate
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South Africa
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Gauteng
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Kwa Zulu-Natal
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South Africa
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Western Cape
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Sweden
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Falköping
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Sweden
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Hässleholm
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Sweden
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Kungälv
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Sweden
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Lidköping
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Varberg
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Sweden
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Växjö
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Sweden
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Örebro
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Taiwan
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Kaohsiung
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Taiwan
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Taoyuan
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United Kingdom
State/province [87] 0 0
Derbyshire
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United Kingdom
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Dumfries and Galloway
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United Kingdom
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Fife
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United Kingdom
State/province [90] 0 0
Greater London
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United Kingdom
State/province [91] 0 0
Merseyside
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United Kingdom
State/province [92] 0 0
Norfolk
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United Kingdom
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Northamptonshire
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00332020
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00332020