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

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.

Timeline

Start

2006-02

Primary completion

2007-05

Completion

2007-06

Outcome

Met primary endpoint

paper The primary outcome occurred in 17 (2.0%) patients in the rivaroxaban group, compared with 81 (9.3%) in the enoxaparin group PMID 18582928 ↗

paper absolute risk reduction 7.3%, 95% CI 5.2-9.4; p<0.0001 PMID 18582928 ↗

Publications

• Kakkar AK, Brenner B, Dahl OE, Eriksson BI, Mouret P, Muntz J, Soglian AG, Pap AF, Misselwitz F, Haas S; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008 Jul 5;372(9632):31-9. doi: 10.1016/S0140-6736(08)60880-6. Epub 2008 Jun 24.

Drugs

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

Indications