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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 (RECORD 2)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00332020
First received: May 30, 2006
Last updated: January 19, 2009
Last verified: January 2009
History of Changes
  Purpose

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.


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

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

Resource links provided by NLM:

U.S. FDA Resources

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

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 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 ]

Enrollment: 2509
Study Start Date: February 2006
Study Completion Date: May 2007
Arms Assigned Interventions
Experimental: Arm 1 Drug: Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
Active Comparator: Arm 2 Drug: Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332020

  Show 126 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00332020     History of Changes
Other Study ID Numbers: 11357, EudraCT: 2005-004691-20
Study First Received: May 30, 2006
Last Updated: January 19, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013