NCT00332020

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

RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,457 (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 can help prevent blood clots forming after a hip replacement operation.

Conditions

• Prevention
• Venous Thromboembolism

Interventions

Type	Name	Description
DRUG	Rivaroxaban (BAY59-7939)	10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days
DRUG	Enoxaparin	40 mg enoxaparin syringe administered for 12 +/- 2 days

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-05-01
• Completion: 2007-06-01
• First posted: 2006-05-31
• Last updated: 2015-01-27

Locations

126 sites across 23 countries: United States, Australia, Brazil, Canada, China, Colombia, Denmark, Estonia, India, Indonesia, Italy, Latvia, Lithuania, Mexico, New Zealand, Norway, Peru, Portugal, South Africa, South Korea, Sweden, Taiwan, United Kingdom