Prevention of venous thromboembolism MedDRA version: 8.1 Level: LLT Classification code 10012108 Term: Deep venous thrombosis prophylaxis
Conditions
Interventions
Product Name: BAY 59-7939
Product Code: BAY 59-7939
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rivaroxaban
CAS Number:
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female patients aged 18 years or above. Patients scheduled for elective total hip replacement. Patients’ written informed consent for participation after receiving detailed written and oral information prior to any study specific procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Planned, staged bilateral total hip replacement 2. Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin. 3. Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local labelling of enoxaparin). 4. Significant liver disease (e.g. acute clinical hepatitis, chronic active hepatitis, cirrhosis) 5. Conditions prohibiting bilateral veno graphy (amputation of one leg, allergy to contrast media). 6. Pregnant and breast-feeding women. Women with child-bearing potential not using adequate birth control method. (Note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible both partners should use adequate barrier birth control). 7. Drug- or alcohol abuse. 8. Concomitant HIV-protease inhibitors. 9. Therapy with another investigational product within 30 days prior start of study. 10. Planned intermittent pneumatic compression during active treatment period. 11. Concomitant participation in another trial or study. 12. Other concomitant medications not allowed (see § 4.5.7 of the study protocol) 13. Ongoing oral anticoagulant therapy that cannot be stopped in the opinion of the investigator. (see § 4.5.7 of the study protocol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this trial is to compare the efficacy and safety of VTE prophylaxis with BAY 59-7939 10 mg once daily administered for 5 weeks to enoxaparin 40 mg once daily (qd) administered for 10-14 days followed by placebo in men and women aged 18 years or above undergoing elective total hip replacement. ;Secondary Objective: ; Primary end point(s): The primary efficacy endpoint is defined as a composite endpoint of: - Any DVT (proximal and/or distal) and - Non fatal PE and - Death from all causes. The analysis of the primary efficacy endpoint will be solely based on the assessments made by the Venography and the VTE Adjudication Committees. Secondary efficacy endpoints are: - Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE-related death (referred to as ‘major VTE’) Further secondary endpoints are given by: - Incidence of DVT (total, proximal, distal) -Incidence of symptomatic VTE (DVT, PE) - Incidence of symptomatic VTE during follow-up (i.e. after the end of the time window for primary efficacy assessment) - 'Net clinical benefit' assessed by the composite endpoint comprising major VTE and treatment-emergent major bleeding (as defined in section 4.6.2 of protocol) - Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death (composite of any DVT and nonfatal PE and VTE-related death) - Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE related death (composite of proximal DVT and nonfatal PE and death from all caus | — |
Countries
Denmark, Estonia, Latvia, Lithuania, Portugal, Sweden, United Kingdom
Outcome results
None listed