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)
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)
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.
Key Inclusion Criteria
Key Exclusion Criteria
Known or suspected hereditary or acquired bleeding or coagulation disorders in the participant or his or her first-degree relative
Known or suspected history of heparin-induced thrombocytopenia
Known coagulopathy
Active bleeding or at high risk for bleeding
Brain, spinal, ophthalmologic, or major surgery or trauma within the past 90 days
Active hepatobiliary disease
Alcohol and/or substance abuse within the past year
Any condition for which, in the opinion of the investigator, surgery or administration of an anticoagulant was contraindicated
Two consecutive blood pressure readings within 15 to 30 minutes with supine systolic blood pressure >180 mm Hg or supine diastolic blood pressure >105 mm Hg
Clinically significant laboratory abnormalities at the enrollment visit:
Belo Horizonte - Mg, Minas Gerais 30130, Brazil
Monaco, 98000, France
Halle/S, 06112, Germany
Kremmen Ot Sommerfeld, 16766, Germany
Jeruselem, 91031, Israel
Randburg, Free State 2194, South Africa
Tygerberg, Western Cape 7505, South Africa
Jeonnam, 519-809, South Korea
Badalona-Barcelona, 08916, Spain
Chernivtsy, 58013, Ukraine