Clinical trial NCT01206972: Dose-confirmatory Bridging Study in Total Knee Replacement
Official title: Randomized, Double-blind, Parallel-group, Active-controlled, Dose-confirmatory Bridging Study of Rivaroxaban (BAY59-7939) 5 to 10 mg Once-daily Regimen With a Reference Drug of Enoxaparin in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Keywords: venous thromboembolism
prevention
orthopaedic surgery
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Scientific Affairs, LLC
First posted: 2010-09-22
Enrollment: 302
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
timeFrame: up to Day 13 (±2 days)
measure: Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
timeFrame: from the first intake of study medication to no later than 2 days after the last intake of study drug
Secondary outcomes:
measure: deep vein thrombosis (total, proximal, distal)
timeFrame: up to Day 13 (±2 days)
measure: symptomatic venous thromboembolism
timeFrame: up to Day 13 (±2 days)
measure: major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
timeFrame: up to Day 13 (±2 days)
measure: symptomatic venous thromboembolism
timeFrame: within 30 days after stop of treatment with study drug
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Matsudo
country: Japan
state: Chiba
city: Matsuyama
country: Japan
state: Ehime
city: Kawanuma
country: Japan
state: Fukushima
city: Koriyama
country: Japan
state: Fukushima
city: Asahikawa
country: Japan
state: Hokkaido
city: Hakodate
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kakogawa
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Nishinomiya
country: Japan
state: Hyogo
city: Tsukuba
country: Japan
state: Ibaraki
city: Iida
country: Japan
state: Nagano
city: Sasebo
country: Japan
state: Nagasaki
city: Tomigusuku
country: Japan
state: Okinawa
city: Hirakata
country: Japan
state: Osaka
city: Izumisano
country: Japan
state: Osaka
city: Izumi
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Kishiwada
country: Japan
state: Osaka
city: Osakasayama
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Adachi
country: Japan
state: Tokyo
city: Nerima-ku
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Saitama
country: Japan
city: Toyama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: