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Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE); a Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement (RECORD 3)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00361894
First received: August 8, 2006
Last updated: January 22, 2009
Last verified: January 2009
History of Changes

August 8, 2006
January 22, 2009
February 2006
Not Provided
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 13+/-4 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00361894 on ClinicalTrials.gov Archive Site
  • Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) [ Time Frame: Treatment period: up to Day 13+/-4 ] [ Designated as safety issue: No ]
  • Incidence of symptomatic VTE (DVT, PE) [ Time Frame: Treatment period: up to Day 13+/-4 ] [ Designated as safety issue: No ]
  • Incidence of DVT (total, proximal, distal) [ Time Frame: Treatment period: up to Day 13+/-4 ] [ Designated as safety issue: No ]
  • Incidence of symptomatic VTE during follow-up [ Time Frame: Follow-up period: following 13+/-4 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 13+/-4 ; 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 13+/-4 ] [ 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 13+/-4 ] [ 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 ]
Not Provided
Not Provided
Not Provided
 
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE); a Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement
RECORD 3 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE; a Controlled., Double-Blind, Randomized Study of BAY 59-7939 in the Prevention of VTE in Subjects Undergoing Elective Total Knee Replacement.

The purpose of this study is to assess if 10 mg Bay 59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Prevention
  • Venous Thromboembolism
  • Drug: Rivaroxaban (BAY59-7939)
    10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
  • Drug: Enoxaparin
    Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days
  • Experimental: Arm 1
    Intervention: Drug: Rivaroxaban (BAY59-7939)
  • Active Comparator: Arm 2
    Intervention: Drug: Enoxaparin
Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2530
January 2007
Not Provided

Inclusion Criteria:

  • Male and female patients aged 18 years or above
  • Patients scheduled for elective total knee replacement

Exclusion Criteria:

  • Active bleeding or high risk of bleeding contraindicating treatment with LMWH
  • Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)
  • Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   China,   Colombia,   Czech Republic,   Denmark,   France,   Germany,   Israel,   Italy,   Mexico,   Netherlands,   Norway,   Peru,   Poland,   South Africa,   Spain,   Sweden
 
NCT00361894
11356, EudraCT: 2005-004620-40
Not Provided
Therapeutic Area Head, Bayer Healthcare Pharmaceuticals Inc.
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
January 2009

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