Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial
Oral Direct Factor Xa Inhibitor BAY 59-7939 in the Prevention of VTE in Patients Undergoing Total Hip Replacement. ODiXahip - a Phase IIa Dose Escalating Proof of Principle Trial
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.
Inclusion Criteria:
Exclusion Criteria:
DVT or PE within the previous 6 months prior to study entry.
Myocardial infarction (MI) or cerebrovascular attack (CVA), TIA or ischaemic stroke within the last 6 months prior to study entry.
History of heparin-induced thrombocytopenia, allergy to heparins.
Intracerebral or intraocular bleeding within the last 6 months prior to study entry.
History of gastrointestinal disease with gastrointestinal bleeding within the last 6 months prior to the study.
History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug
Amputation of one leg.Related to current symptoms or findings
Heart insufficiency NYHA III-IV.
Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits).
Thrombocytopenia (platelets < 50.000/µl).
Macroscopic haematuria.
Allergy to contrast media.
Severe hypertension (SBP > 200mmHg, DBP > 100 mmHg).
Impaired liver function (transaminases > 2 x ULN).
Impaired renal function (serum creatinine > 1.5 x ULN).
Active malignant disease.
Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding.
Body weight < 45 kg.
Drug- or alcohol abuse.
Related to current treatment