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.

Venous Thromboembolism Clinical Trial

— RECORD 3  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00361894
• Other study ID #: 11356
• Secondary ID: EudraCT: 2005-00
• Status: Completed
• Phase: Phase 3
• First received: August 8, 2006
• Last updated: October 24, 2014
• Start date: February 2006
• Est. completion date: January 2007

Study information

• Verified date: October 2014
• 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 prevents blood clot which may form after a knee replacement operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2531
• Est. completion date: January 2007
• Est. primary completion date: January 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 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)

Study Design

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

Related Conditions & MeSH terms

• Prevention
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (BAY59-7939)
10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
• Enoxaparin
Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Belgium,  Canada,  China,  Colombia,  Czech Republic,  Denmark,  France,  Germany,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  South Africa,  Spain,  Sweden, 

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 13+/-4	No
Secondary	Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)		Treatment period: up to Day 13+/-4	No
Secondary	Incidence of symptomatic VTE (DVT, PE)		Treatment period: up to Day 13+/-4	No
Secondary	Incidence of DVT (total, proximal, distal)		Treatment period: up to Day 13+/-4	No
Secondary	Incidence of symptomatic VTE during follow-up		Follow-up period: following 13+/-4 days	No
Secondary	The composite endpoint comprising major VTE and treatment-emergent major bleeding		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	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 13+/-4	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 13+/-4	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

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.
•   Click here to find information about studies related to Bayer Healthcare products conducted in Europe
•   Click here to find results for studies related to Bayer Healthcare products.