Table 1

Summary of clinical studies of new oral anticoagulant agents in the prevention of venous thromboembolism after major orthopedic surgery

Study	Phase	Surgery	Dosing	Comparator(s)	Status
Dabigatran etexilate^*
RE-NOVATE	III	THA	150 and 220 mg od	Enoxaparin	Completed
RE-MODEL	III	TKA	150 and 220 mg od	Enoxaparin	Completed
RE-MOBILIZE	III	TKA	150 and 220 mg od	Enoxaparin^‡	Completed
RE-NOVATE II	III	THA	220 mg od	Enoxaparin	Completed
Rivaroxaban^†
RECORD1	III	THA	10 mg od	Enoxaparin	Completed
RECORD2	III	THA	10 mg od	Enoxaparin	Completed
RECORD3	III	TKA	10 mg od	Enoxaparin	Completed
RECORD4	III	TKA	10 mg od	Enoxaparin^‡	Completed
Apixaban
ADVANCE-1 (NCT00371683)	III	TKA	2.5 mg bid	Enoxaparin^‡	Completed
ADVANCE-2 (NCT00452530)	III	TKA	2.5 mg bid	Enoxaparin	Completed
ADVANCE-3 (NCT00423319)	III	THA	2.5 mg bid	Enoxaparin	Completed
YM150
ONYX	II	THA	3–60 mg od	Enoxaparin	Completed
ONYX-2	II	THA	5–120 mg od	Enoxaparin	Completed
PEARL-1 (NCT00408239)	II	TKA	Escalating doses (bid or od)	Enoxaparin	Completed
PEARL-2 (NCT00595426)	II	TKA	bid or od	Warfarin	Completed
ONYX-3 (NCT00902928)	II/III	THA	bid or od	Enoxaparin	Ongoing
Edoxaban (DU-176b)
NCT00107900	II	THA	Dose ranging	—	Completed
NCT00398216	II	THA	Dose ranging	Dalteparin	Completed
Betrixaban
EXPERT	II	TKA	15 or 40 mg od	Enoxaparin^‡	Completed

bid = twice daily; od = once daily; THA = total hip arthroplasty; TKA = total knee arthroplasty; VTE = venous thromboembolism.
↵* Dabigatran etexilate was approved in the European Union and Canada for the prevention of VTE after THA and TKA in 2008.
↵† Rivaroxaban was approved in the European Union, Canada and several other countries for the prevention of VTE after THA and TKA in 2008.
↵‡ Enoxaparin 30 mg bid.
Source: www.clinicaltrials.gov.