Venous Thromboembolism
Conditions
Keywords
venous thromboembolism, prevention, orthopaedic 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 knee replacement (TKR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase III study (RECORD 3 - Study 11356) and phase II studies.
Interventions
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
DRUGEnoxaparin
daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)
Sponsors
Janssen Scientific Affairs, 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 TKR (the first replacement of the applicable knee 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 TKR 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 TKR 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 13 (±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 |
Secondary
| Measure | Time frame |
|---|---|
| deep vein thrombosis (total, proximal, distal) | up to Day 13 (±2 days) |
| symptomatic venous thromboembolism | up to Day 13 (±2 days) |
| major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death) | up to Day 13 (±2 days) |
Countries
Japan
Outcome results
None listed