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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Prevention, Venous Thromboembolism

Intervention / Treatment
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* Drug: Rivaroxaban (BAY59-7939)
* Drug: Enoxaparin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rivaroxaban (BAY59-7939)<br>* 10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days<br>|
| Active Comparator: Arm 2<br> | Drug: Enoxaparin<br>* Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE) |  | Treatment period: up to Day 13+/-4 | 
| Incidence of symptomatic VTE (DVT, PE) |  | Treatment period: up to Day 13+/-4 | 
| Incidence of DVT (total, proximal, distal) |  | Treatment period: up to Day 13+/-4 | 
| Incidence of symptomatic VTE during follow-up |  | Follow-up period: following 13+/-4 days | 
| 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 | 
| 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 | 
| 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 | 
| 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 |