Venous Thromboembolism
Conditions
Keywords
Venous Thromboembolism, Prevention, Arthroplasty, Replacement, Hip, orthopedic surgery
Brief summary
The primary objective is to: * demonstrate the efficacy of SR123781A in the prevention of venous thromboembolism (VTE) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. The secondary objectives are to: * evaluate the safety of SR123781A in the prevention of VTE after elective total hip replacement surgery; and * to assess the SR123781A pharmacokinetic profile in patients undergoing elective total hip replacement surgery.
Interventions
DRUGSR123781A
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry
Exclusion criteria
* Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization * Known progressive malignant disease * Ischemic stroke in the last 3 months * Myocardial infarction (MI) in the last 3 months * Any major orthopedic surgery in the 3 months prior to study start * Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound DVT/PE assessments) * Treatment with other antithrombotic agents within 7 days prior to surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint is a composite of total venous thromboembolic events (VTE) including VTE related deaths during the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy endpoints will include all deep vein thrombosis events [DVTs] (proximal or distal) and all symptomatic VTEs (pulmonary embolisms [PEs] or DVTs) | — |
| The main safety criterion is the incidence of major bleedings occurring from the first study drug administration to 3 calendar days after the last study drug administration. | — |
Countries
Argentina, Bulgaria, Chile, Colombia, Czechia, Denmark, Finland, Mexico, Norway, Poland, Romania, Russia, Sweden, Turkey (Türkiye)
Outcome results
None listed