Trial Condition(s):
Venous Thromboembolism
Dose-confirmatory bridging study in total knee replacement
Bayer Identifier:
14398
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Asahikawa, Japan, 078-8237 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hakodate, Japan, 040-8611 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Koriyama, Japan, 963-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawanuma, Japan, 969-6593 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tsukuba, Japan, 305-0854 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saitama, Japan, 336-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsudo, Japan, 271-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nerima-ku, Japan, 177-8521 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adachi, Japan, 121-0064 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Iida, Japan, 395-8505 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nagoya, Japan, 455-8530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 602-8026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 530-0012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 558-8558 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-1192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hirakata, Japan, 573-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sakai, Japan, 599-8271 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kishiwada, Japan, 596-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kishiwada, Japan, 596-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izumisano, Japan, 598-8577 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izumi, Japan, 594-0071 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 657-0068 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nishinomiya, Japan, 663-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kakogawa, Japan, 675-8545 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 813-0017 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fukuoka, Japan, 819-8551 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Saga, Japan, 849-8501 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sasebo, Japan, 857-8575 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tomigusuku, Japan, 901-0243 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toyama, Japan, 930-8550 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Matsuyama, Japan, 790-8524 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sapporo, Japan, 060-8648 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
4
Primary Outcome
- A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causesTimeframe: up to Day 13 (±2 days)
- 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 Outcome
- deep vein thrombosis (total, proximal, distal)Timeframe: up to Day 13 (±2 days)
- symptomatic venous thromboembolismTimeframe: up to Day 13 (±2 days)
- major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)Timeframe: up to Day 13 (±2 days)
- symptomatic venous thromboembolismTimeframe: within 30 days after stop of treatment with study drug
Additional Information
Copyright © Bayer
Powered by
