Rivaroxban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00329628

First received: May 24, 2006

Last updated: January 22, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2006

Last Updated Date

January 22, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00329628 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period : up to day 36+/-6 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 36+/-6 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Rivaroxban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Venous Thromboembolism

Intervention ^ICMJE

Drug: Rivaroxaban (BAY59-7939)
10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
Drug: Enoxaparin
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days

Study Arm (s)

Experimental: Arm 1
Intervention: Drug: Rivaroxaban (BAY59-7939)
Active Comparator: Arm 2
Intervention: Drug: Enoxaparin

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4000

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Slovakia, South Africa, Spain, Sweden, Turkey

Administrative Information

NCT Number ^ICMJE

NCT00329628

Other Study ID Numbers ^ICMJE

11354, EudraCT: 2005-004351-35

Has Data Monitoring Committee

Not Provided

Responsible Party

Therapeutic Area Head, Bayer HealthCare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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