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.

Phase 3 Completed 2531 enrolled Bayer

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2006-02
Primary completion: 2007-01
Completion: 2007-01

Publications

Lassen MR, Ageno W, Borris LC, Lieberman JR, Rosencher N, Bandel TJ, Misselwitz F, Turpie AG; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008 Jun 26;358(26):2776-86. doi: 10.1056/NEJMoa076016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Enoxaparin sodium	Other / unclassified	40 mg	Subcutaneous
Subject	Rivaroxaban	Other / unclassified	10 mg	Oral

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.

Summary

Timeline

Publications

Drugs

Indications