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

Venous Thromboembolism Clinical Trial

— RECORD 2  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332020
• Other study ID #: 11357
• Secondary ID: 2005-004691-20
• Status: Completed
• Phase: Phase 3
• First received: May 30, 2006
• Last updated: January 26, 2015
• Start date: February 2006
• Est. completion date: June 2007

Study information

• Verified date: January 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2457
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Prevention
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
• Enoxaparin
40 mg enoxaparin syringe administered for 12 +/- 2 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes		Treatment period: up to day 35+/-6	No
Secondary	Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)		Treatment period: up to day 35+/-6	No
Secondary	Incidence of symptomatic VTE (DVT, PE)		Treatment period: up to day 35+/-6	No
Secondary	Incidence of DVT (total, proximal, distal)		Treatment period: up to day 35+/-6	No
Secondary	Incidence of symptomatic VTE during follow-up		Follow-up period: following 35+/-6 days	No
Secondary	The composite endpoint comprising major VTE and treatment-emergent major bleeding		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	No
Secondary	Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death		Treatment period: up to day 35+/-6	No
Secondary	Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death		Treatment period: up to day 35+/-6	No
Secondary	Treatment-emergent major bleedings		From first dose of double-blind study medication to up to two days after last dose of double-blind study medication	Yes

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