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 - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2006

Last Updated Date

January 19, 2009

Start Date ^ICMJE

February 2006

Primary Completion Date

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 35+/-6 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal)
Non fatal PE
Death of all causes

Change History

Complete list of historical versions of study NCT00332020 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 35+/-6 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to day 35+/-6 ] [ Designated as safety issue: No ]
Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 35+/-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 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 ] [ 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 35+/-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 35+/-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

Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death
Incidence of symptomatic VTE (DVT, PE)
Incidence of DVT (total, proximal, distal)
Bleeding events

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Prevention
Venous Thromboembolism

Intervention ^ICMJE

Drug: Rivaroxaban (BAY59-7939)
Drug: Enoxaparin

Study Arms / Comparison Groups

Publications *

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. Epub 2008 Jun 24.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

2509

Completion Date

May 2007

Primary Completion Date

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, Australia, Brazil, Canada, China, Colombia, Denmark, Estonia, India, Indonesia, Italy, Korea, Republic of, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Portugal, South Africa, Sweden, Taiwan, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00332020

Responsible Party

Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.

Study ID Numbers ^ICMJE

11357, EudraCT: 2005-004691-20

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

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