Controlled, Double-Blind, Randomised, Dose-Ranging Study on the Prevention of VTE in Patients Undergoing Elective Total Hip Replacement- ODIXa-HIP2 Study BAY 59-7939
Overview
- Phase
- Phase 2
- Intervention
- Rivaroxaban (Xarelto, BAY59-7939)
- Conditions
- Venous Thromboembolism
- Sponsor
- Bayer
- Enrollment
- 726
- Primary Endpoint
- Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk, but heparins have to be applied by injections below the skin. The purpose of this study was to compare the safety and efficacy of BAY 59-7939 with the safety and efficacy of the licensed drug enoxaparin and to find the optimal dose of BAY 59-7939 for the anticipated phase III trials. Enoxaparin, a so-called low molecular weight heparin, is approved and widely used in the area of thromboprophylaxis and was given once daily subcutaneously. In this study 5 different doses of the investigational drug BAY 59-7939 were tested in comparison to Enoxaparin. The following doses of BAY 59-7939 were tested: 2.5 mg twice daily (5 mg total daily dose); 5 mg twice daily (10 mg total daily dose), 10 mg twice daily (20 mg total daily dose), 20 mg twice daily (40 mg total daily dose) and 30 mg twice daily ( 60 mg total daily dose). This study ran for approximately 7 months in a number of countries. In total, 726 patients were enrolled in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male patients aged 18 years or above and postmenopausal female patients
- •Patients scheduled for elective primary total hip replacement (cemented or non-cemented prosthesis
- •Patients written informed consent for participation after receiving detailed written and oral previous information to any study specific procedures
Exclusion Criteria
- •Any VTE prior to randomization
- •Myocardial infarction (MI) or TIA or ischaemic stroke within the last 6 months prior to randomisation
- •History of heparin-induced thrombocytopenia, allergy to heparins
- •Intracerebral or intraocular bleeding within the last 6 months prior to randomisation
- •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 (e.g. severe active inflammatory bowel disease, short gut syndrome)
- •Amputation of one leg
- •Heart insufficiency NYHA III-IV
- •Congenital or acquired haemorrhagic diathesis (PT INR/aPTT not within normal limits) including patients with acquired or congenital thrombopathy
- •Thrombocytopenia (platelets \< 100.000/µl)
Arms & Interventions
Arm 1
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Arm 2
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Arm 3
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Arm 4
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Arm 5
Intervention: Rivaroxaban (Xarelto, BAY59-7939)
Arm 6
Intervention: Enoxaparin
Outcomes
Primary Outcomes
Composite Endpoint: Any Deep Vein Thrombosis (DVT) (proximal and/or distal) and Non fatal Pulmonary Embolism (PE) and Death from all causes
Time Frame: 5-9 days after surgery
Secondary Outcomes
- Incidence of DVTs (total, proximal, distal)(5-9 days after surgery)
- Incidence of symptomatic Venous Thrombo Embolisms (VTEs)(5-9 days after surgery)
- Incidence of symptomatic VTEs (total, PE, DVT) within 30 days after stop of treatment with the study drug(40 days)
- Healthcare Resource Utilisation Questionnaire(9 days and 40 days after surgery)