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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/NCT00329628




Registration number
NCT00329628
Ethics application status
Date submitted
24/05/2006
Date registered
25/05/2006
Date last updated
28/10/2014

Titles & IDs
Public title
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
Scientific title
RECORD 1 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 Total Hip Replacement
Secondary ID [1] 0 0
EudraCT: 2005-004351-35
Secondary ID [2] 0 0
11354
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 OD tablet of rivaroxaban administered for 36 +/- 4 days

Treatment: Drugs: Enoxaparin
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 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 36+/-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 36+/-6
Secondary outcome [2] 0 0
Incidence of symptomatic VTE (DVT, PE)
Timepoint [2] 0 0
Treatment period : up to day 36+/-6
Secondary outcome [3] 0 0
Incidence of DVT (total, proximal, distal)
Timepoint [3] 0 0
Treatment period : up to day 36+/-6
Secondary outcome [4] 0 0
Incidence of symptomatic VTE during follow-up
Timepoint [4] 0 0
Follow-up period: following 36+/-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 36+/-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 36+/-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 36+/-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
1/03/2007
Sample size
Target
Accrual to date
Final
4541
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
- Sydney
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Fremantle
Recruitment postcode(s) [1] 0 0
2217 - Sydney
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3128 - Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Melbourne
Recruitment postcode(s) [5] 0 0
6160 - Fremantle
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Asturias
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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 prevent blood clot which may form after total hip replacement operation.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00329628
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/NCT00329628