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

This study has been completed.
Information provided by:
Bayer Identifier:
First received: May 24, 2006
Last updated: October 27, 2014
Last verified: October 2014
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.

Condition Intervention Phase
Venous Thromboembolism
Drug: Rivaroxaban (BAY59-7939)
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 Measures:
  • 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 ]
  • Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period : up to day 36+/-6 ]
  • Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period : up to day 36+/-6 ]
  • Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 36+/-6 days ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 4541
Study Start Date: February 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (BAY59-7939)
10 mg OD tablet of rivaroxaban administered for 36 +/- 4 days
Active Comparator: Arm 2 Drug: Enoxaparin
Syringe of Enoxaparin active substance at a dose of 40 mg administered for 13 +/- 2 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00329628

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Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Bayer HealthCare AG Identifier: NCT00329628     History of Changes
Other Study ID Numbers: 11354
EudraCT: 2005-004351-35
Study First Received: May 24, 2006
Last Updated: October 27, 2014

Keywords provided by Bayer:

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on May 25, 2017