At a glance
ClinicalIndex Comparison Record- ✓Scheduled for elective unilateral or same-day bilateral total knee replacement surgery, or revision of at least 1 component of a TKR
- ✓Willing and able to undergo bilateral ascending contrast venography
- ✕Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or first-degree relative
- ✕Known or suspected history of heparin-induced thrombocytopenia
- ✕Active bleeding or at high risk for bleeding
- ✕Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-blind, Active-controlled (Enoxaparin 40 mg QD), Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery (The ADVANCE - 2 Study)
In Brief
A Phase 3 clinical trial evaluating Enoxaparin, Apixaban, and 2 other interventions for Deep Vein Thrombosis and Pulmonary Embolism. Completed, enrolled 3,221 participants across 122 sites in 27 countries.
Detailed Summary
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.
Study Details
Timeline
Interventions
40 mg, administered once daily by subcutaneous injection, for 12 days
2.5 mg, administered twice daily as tablets, for 12 days
Administered once daily by subcutaneous injection
Oral tablet administered twice daily