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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
302
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
Unnamed facility
Nagoya, Aichi-ken, Japan
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 13 (±2 days)
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
deep vein thrombosis (total, proximal, distal)
Time frame: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time frame: up to Day 13 (±2 days)
major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
Time frame: up to Day 13 (±2 days)
symptomatic venous thromboembolism
Time frame: within 30 days after stop of treatment with study drug
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daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)
Unnamed facility
Matsudo, Chiba, Japan
Unnamed facility
Matsuyama, Ehime, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Fukuoka, Fukuoka, Japan
Unnamed facility
Kawanuma, Fukushima, Japan
Unnamed facility
Kōriyama, Fukushima, Japan
Unnamed facility
Asahikawa, Hokkaido, Japan
Unnamed facility
Hakodate, Hokkaido, Japan
Unnamed facility
Sapporo, Hokkaido, Japan
...and 23 more locations