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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ 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 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 ]

Enrollment: 4000
Study Start Date: February 2006
Study Completion Date: March 2007
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329628

  Show 215 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
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 AG
ClinicalTrials.gov Identifier: NCT00329628     History of Changes
Other Study ID Numbers: 11354, EudraCT: 2005-004351-35
Study First Received: May 24, 2006
Last Updated: January 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Prevention
Thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Thrombosis
Vascular Diseases
Rivaroxaban
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014