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

Phase 3

Completed

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

• Registration Number: NCT00332020
• 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 can help prevent blood clots forming after a hip replacement operation.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-05-30
• Study First Submitted QC: 2006-05-30
• Study First Posted: 2006-05-31
• Primary Completion: 2007-05
• Study Completion: 2007-06
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-26
• Last Update Posted: 2015-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2457

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 35+/-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 35+/-6
Incidence of symptomatic VTE (DVT, PE)	Treatment period: up to day 35+/-6
Incidence of DVT (total, proximal, distal)	Treatment period: up to day 35+/-6
Incidence of symptomatic VTE during follow-up	Follow-up period: following 35+/-6 days
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
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
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
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