Back to resultsRivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
Primary Purpose
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 Venous Thromboembolism focused on measuring Prevention, Thromboembolism
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
NCT00329628
Brief Title
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 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 prevent blood clot which may form after total hip 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, Thromboembolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4541 (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 OD tablet of rivaroxaban administered for 36 +/- 4 days
Intervention Type
Drug
Intervention Name(s)
Enoxaparin
Intervention Description
Syringe of Enoxaparin active substance at a dose of 40 mg administered 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 36+/-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 36+/-6
Title
Incidence of symptomatic VTE (DVT, PE)
Time Frame
Treatment period : up to day 36+/-6
Title
Incidence of DVT (total, proximal, distal)
Time Frame
Treatment period : up to day 36+/-6
Title
Incidence of symptomatic VTE during follow-up
Time Frame
Follow-up period: following 36+/-6 days
Title
The composite endpoint comprising major VTE and treatment-emergent major bleeding
Time Frame
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
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 36+/-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 36+/-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
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Alabama
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35205
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United States
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Northport
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Alabama
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35476
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United States
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Phoenix
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Arizona
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85023
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United States
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Benton
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Arkansas
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72015
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United States
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La Jolla
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California
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92037
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United States
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Aurora
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Colorado
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80012
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United States
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Decatur
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Georgia
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30033
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United States
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Missoula
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Montana
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59802
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United States
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29414
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United States
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Texas
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76051
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United States
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Lubbock
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Texas
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79410
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United States
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San Antonio
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Texas
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78233
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United States
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Avellaneda
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Buenos Aires
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1870
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Argentina
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Berazategui
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Buenos Aires
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1884
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Argentina
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Buenos Aires
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Capital Federal
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1426
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Argentina
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Buenos Aires
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Capital Federal
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C1039AAO
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Argentina
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Buenos Aires
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Capital Federal
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C1280AEB
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Argentina
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Buenos Aires
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Capital Federal
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C1406FWY
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Argentina
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Buenos Aires
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C1425AGP
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Sydney
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New South Wales
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Adelaide
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5042
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Victoria
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Fremantle
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Wiener Neustadt
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Niederösterreich
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2700
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Austria
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Linz
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Oberösterreich
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4010
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Austria
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Linz
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Oberösterreich
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4020
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4910
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4600
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Austria
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8036
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Austria
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Innsbruck
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Tirol
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6020
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Wien
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Antwerpen
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2020
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Brasschaat
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Brugge
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8000
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Nantes Cedex 2
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Heidelberg
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Germany
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Rheinfelden
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Baden-Württemberg
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Bayern
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Bayern
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Germany
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Hessen
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Hessen
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Mecklenburg-Vorpommern
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Düsseldorf
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Nordrhein-Westfalen
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40225
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Germany
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Witten
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Nordrhein-Westfalen
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Germany
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Dresden
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Sachsen
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Bremen
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28205
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Haidari
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Attica
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Greece
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Attica
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Greece
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Bekescsaba
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5600
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Hungary
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Budapest
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1076
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Hungary
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Budapest
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1089
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Hungary
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Györ
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9024
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Hungary
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Kaposvar
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Kecskemet
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Hungary
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Szeged
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Hungary
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Szekesfehervar
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Hungary
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Szekszard
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Beer Sheva
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Israel
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Haifa
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31096
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Israel
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Holon
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58100
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Israel
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Kfar Saba
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44281
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Israel
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Petach Tikva
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49100
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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52621
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Israel
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Zerifin
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70300
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Israel
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Monza
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Milano
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20052
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Italy
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Rozzano
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Milano
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20089
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Italy
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San Donato Milanese
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Milano
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20097
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Italy
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Gubbio
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Perugia
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06024
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Italy
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Alghero
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Sassari
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07041
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Italy
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Varese
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21052
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Italy
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Ancona
ZIP/Postal Code
60126
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Italy
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Bergamo
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24128
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Italy
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Bologna
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40136
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Italy
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Ferrara
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44100
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Italy
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Firenze
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50139
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Italy
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Genova
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16132
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Italy
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Milano
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20132
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Italy
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Milano
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20162
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Italy
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Palermo
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90129
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Reggio Emilia
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42100
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Italy
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00168
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Sassari
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Torino
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Kaunas
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Vilnius
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Monterrey
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Nuevo Leon
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64380
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Mexico
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64460
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2134 TM
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Leiden
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2334 CK
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Nijmegen
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OSS
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5342 BT
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1306
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2409
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Norway
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2819
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Norway
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Lillehammer
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2609
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NO-3675
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15-276
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85-094
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Poland
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85-681
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Poland
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Gdansk
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80-803
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40-635
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Poland
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Krakow
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30-901
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Krakow
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31-826
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Poland
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Krakow
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31-913
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Poland
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Lodz
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91-002
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Poland
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Lublin
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20-090
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Poland
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Lublin
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20-718
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Poland
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45-060
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Poland
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Poznan
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60-703
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41-200
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Szczecin
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71-252
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Warszawa
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00-909
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Poland
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Warszawa
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02-005
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Warszawa
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03-242
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Wroclaw
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51-128
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Bratislava
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826 06
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040 15
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012 07
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Slovakia
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Pretoria
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Gauteng
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0084
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Somerset West
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Western Cape
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7130
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South Africa
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Worcester
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Western Cape
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6850
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South Africa
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Santiago de Compostela
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A Coruña
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15706
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Spain
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Oviedo
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Asturias
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33006
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Spain
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Badalona
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Barcelona
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08916
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Spain
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L'Hospitalet de llobregat
State/Province
Barcelona
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08906
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Spain
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Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
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Spain
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Barcelona
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08003
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Spain
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Barcelona
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08006
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Spain
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Barcelona
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08025
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Spain
City
Barcelona
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08035
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Spain
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Barcelona
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08036
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Spain
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Castellón de la Plana
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12004
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Spain
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Jaén
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23007
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Spain
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Madrid
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28040
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Spain
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Pamplona
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31008
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Spain
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Valencia
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46010
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Spain
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Vitoria
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01009
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Spain
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Göteborg
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416 85
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Sweden
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Halmstad
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301 85
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Sweden
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Jönköping
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551 85
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Sweden
City
Lidköping
ZIP/Postal Code
531 85
Country
Sweden
City
Varberg
ZIP/Postal Code
432 81
Country
Sweden
City
Västervik
ZIP/Postal Code
593 81
Country
Sweden
City
Adana
ZIP/Postal Code
01330
Country
Turkey
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
18579811
Citation
Eriksson BI, Borris LC, Friedman RJ, Haas S, Huisman MV, Kakkar AK, Bandel TJ, Beckmann H, Muehlhofer E, Misselwitz F, Geerts W; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2765-75. doi: 10.1056/NEJMoa0800374.
Results Reference
derived
Links:
URL
http://www.clinicaltrialsregister.eu
Description
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Learn more about this trial
Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin
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