Venous Thromboembolism
Conditions
Keywords
venous thromboembolism, prevention, othopaedic surgery
Brief summary
The objective of this dose-confirmatory bridging study is to investigate the safety and efficacy of rivaroxaban 5 to 10 mg once-daily (od) dosing in the prevention of venous thromboembolism (VTE) in Japanese patients undergoing elective total hip replacement (THR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase II study (ODIXa-OD.HIP - Study 11527).
Interventions
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
DRUGEnoxaparin
daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
Sponsors
Janssen Research & Development, LLC
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 20 years or above * Patients undergoing elective THR (the first replacement of the applicable hip joint) * Patients' written informed consent to participation after receiving detailed verbal and written information on any study specific procedures in advance
Exclusion criteria
* Planned, staged major orthopedic surgery within 3 months prior to elective THR or during this study * History of clinically significant active bleeding (e.g. intracranial bleeding, gastrointestinal bleeding\*), or high bleeding risk \*: within 3 months prior to elective THR for gastrointestinal bleeding * Subjects with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk * Severe impaired renal function (CLCR calculated by Cockcroft-Gault formula: \<30 mL/min) * Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media) * Ongoing anticoagulant therapy (e.g. warfarin, heparins and Factor Xa inhibitors other than study medication) that cannot be stopped (in the opinion of the investigator/sub investigator) * Subjects for whom epidural catheters are expected to be left in for longer than 18 hours post-operatively * Planned intermittent pneumatic compression during treatment period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes | Up to Day 9 (±2 days) |
| Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) | Up to Day 8 (±2 days) |
Secondary
| Measure | Time frame |
|---|---|
| Deep vein thrombosis (total, proximal, distal) | up to Day 9 (±2 days) |
| Symptomatic venous thromboembolism | up to Day 9 (±2 days) |
| Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death) | up to Day 9 (±2 days) |
| Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) | from the first intake of study medication to no later than 2 days after the last intake of study drug |
Countries
Japan
Outcome results
None listed