Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE (up to 60 % without prophylaxis). The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied below the skin (subcutaneously). Additionally, there is a chance of developing a heparin-induced thrombocytopenia (decrease in platelets). Therefore, there is still a need for new agents which are safer and more efficient and which are easier to apply.The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously.Another important purpose of the study is to find the optimal dose of BAY 59-7939 for thromboprophylaxis after hip replacement surgery. Therefore, there are several dose steps planned.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
641
2,5 mg bid,5 mg bid,10mg bid, 20 mg bid, 20 mg tid, 30 mg bid, dose escalation trial
40 mg bid
Unnamed facility
Wiener Neustadt, Lower Austria, Austria
Unnamed facility
Linz, Upper Austria, Austria
Unnamed facility
Vienna, Vienna, Austria
Unnamed facility
Baudour, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Huy, Belgium
Unnamed facility
Hellerup, Denmark
Unnamed facility
Herlev, Denmark
Unnamed facility
Hørsholm, Denmark
...and 31 more locations
The primary efficacy endpoint is a composite endpoint of: - Any DVT (proximal and/or distal) and - Non fatal PE and - Death from all causes. The primary endpoint will be evaluated 5 - 9 days after surgery.
Time frame: Assymptomatic DVT will be measured 5-9 days after surgery Symptomatc DVT , non-fatal PE and Death from all causes will be measured 41 days after surgery
Incidence of DVTs (total, proximal, distal)
Time frame: will be evaluated 5 - 9 days after surgery.
Incidence of symptomatic VTEs
Time frame: 41 days after surgery
The composite endpoint that results from the primary endpoint by using alternative definition of deaths (i.e. VTE related death)
Time frame: 41 days after surgery
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug.
Time frame: 41 days after surgery
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