NCT00361894

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.

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,531 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prevention
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban (BAY59-7939)	10 mg rivaroxaban (tablet) once daily administered for 13 +/- 2 days
DRUG	Enoxaparin	Syringe of enoxaparin at a dose of 40 mg for 13 +/- 2 days

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2006-08-09
• Last updated: 2014-10-27

Locations

143 sites across 19 countries: Austria, Belgium, Canada, China, Colombia, Czechia, Denmark, France, Germany, Israel, Italy, Mexico, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden