NCT00371683

Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery

A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,608 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Conditions

• Deep Vein Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DRUG	Enoxaparin + Placebo	Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
DRUG	Apixaban + Placebo	Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2006-09-04
• Last updated: 2015-12-30
• Results posted: 2015-12-30

Locations

107 sites across 13 countries: United States, Argentina, Australia, Brazil, Canada, Denmark, Hungary, Israel, Mexico, Poland, Russia, Sweden, Turkey (Türkiye)