Rivaroxaban (10mg) Given Once Daily in Patients Undergoing Total Hip Replacement Compared to Enoxaparin

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Rivaroxaban (BAY59-7939); Drug: Enoxaparin

• Registration Number: NCT00329628
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-25
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4541

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Rivaroxaban (BAY59-7939)	-
Arm 2	Enoxaparin	-

Primary Outcome Measures

Name	Time	Method
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 36+/-6

Secondary Outcome Measures

Name	Time	Method
Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)	Treatment period : up to day 36+/-6
Incidence of DVT (total, proximal, distal)	Treatment period : up to day 36+/-6
Incidence of symptomatic VTE (DVT, PE)	Treatment period : up to day 36+/-6
The composite endpoint comprising major VTE and treatment-emergent major bleeding	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
Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death	Treatment period : up to day 36+/-6
Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death	Treatment period : up to day 36+/-6
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
Incidence of symptomatic VTE during follow-up	Follow-up period: following 36+/-6 days