Xarelto for VTE Prophylaxis After Hip or Knee Arthroplasty

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Standard care treatment for VTE prophylaxis; Drug: Rivaroxaban (Xarelto, BAY59-7939)

• Registration Number: NCT00831714
• Lead Sponsor: Bayer

Brief Summary

The main goal is to provide additional information to the risk-benefit assessment of the drug.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2009-01-28
• Study First Submitted QC: 2009-01-28
• Study First Posted: 2009-01-29
• Study Start: 2009-02
• Primary Completion: 2011-06
• Study Completion: 2013-04
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19076

Inclusion Criteria

• Female and male patients who will undergo elective hip or knee arthroplasty.

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Standard care treatment for VTE prophylaxis	-
Group 1	Rivaroxaban (Xarelto, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
Data collection on: Bleeding events reported as serious or non-serious adverse events; Symptomatic thromboembolic events (DVT, PE) reported as adverse events; Uncommon adverse events (incidence rate between 0.1 % and 1 %); All cause mortality	During observation period of three months