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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
402
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
Time frame: Up to Day 9 (±2 days)
Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
Time frame: Up to Day 8 (±2 days)
Deep vein thrombosis (total, proximal, distal)
Time frame: up to Day 9 (±2 days)
Symptomatic venous thromboembolism
Time frame: up to Day 9 (±2 days)
Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death)
Time frame: up to Day 9 (±2 days)
Symptomatic venous thromboembolism
Time frame: up to Day 36 (±4 days)
Symptomatic venous thromboembolism
Time frame: within 30 days after stop of treatment with study drug.
Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
Time frame: from the first intake of study medication to no later than 2 days after the last intake of study drug
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daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
Unnamed facility
Nagoya, Aichi-ken, Japan
Unnamed facility
Matsudo, Chiba, Japan
Unnamed facility
Narashino, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kōriyama, Fukushima, Japan
Unnamed facility
Asahikawa, Hokkaido, Japan
Unnamed facility
Hakodate, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 31 more locations