The purpose of this study is to assess different doses of a new drug (BAY 59-7939), taken as a tablet, are safe and can help prevent blood clots forming after a hip replacement operation. Patients undergoing hip replacement surgery are at risk of developing blood clots. To reduce this risk treatment to prevent clots forming is routinely given. The current treatments can include injections under the skin or other treatments that need frequent blood tests to monitor levels of drug in the body. Therefore there is a need for new drugs, which are easier to give and need less monitoring.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
877
Rivaroxaban 5 mg once daily plus placebo enoxaparin syringe
Rivaroxaban 10 mg once daily plus placebo enoxaparin syringe
Rivaroxaban 20 mg once daily plus placebo enoxaparin syringe
Rivaroxaban 30 mg once daily plus placebo enoxaparin syringe
Rivaroxaban 40 mg once daily plus placebo enoxaparin syringe
Enoxaparin 40 mg once daily plus Rivaroxaban placebo tablets
Unnamed facility
Wiener Neustadt, Lower Austria, Austria
Unnamed facility
Linz, Upper Austria, Austria
Unnamed facility
Linz, Upper Austria, Austria
Unnamed facility
Vienna, Vienna, Austria
Unnamed facility
Antwerp, Belgium
Unnamed facility
Composite Endpoint of Deep Vein Thrombosis (DVT), non-fatal Pulmonary Embolism (PE) and Death from all causes
Time frame: 6-10 days after surgery
Incidence of DVTs (total, proximal, distal)
Time frame: 6-10 days after surgery
Incidence of symptomatic Venous Thrombo Embolisms (VTEs)
Time frame: 6-10 days after surgery
Incidence of major VTE (ie, Proximal DVT, PE or VTE-related death)
Time frame: 6-10 days after surgery
The composite endpoint that results from the primary endpoint by substituting VTE related death for all death
Time frame: 40 days
Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug
Time frame: 40 days
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Bonheiden, Belgium
Unnamed facility
Genk, Belgium
Unnamed facility
Hasselt, Belgium
Unnamed facility
Hellerup, Denmark
Unnamed facility
Herlev, Denmark
...and 52 more locations