Status:
COMPLETED
Dose-confirmatory Bridging Study in Total Knee Replacement
Lead Sponsor:
Bayer
Collaborating Sponsors:
Janssen Scientific Affairs, LLC
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 J...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01206972
Start Date
October 1 2010
End Date
June 1 2011
Last Update
January 18 2017
Active Locations (33)
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1
Nagoya, Aichi-ken, Japan, 455-8530
2
Matsudo, Chiba, Japan, 271-8511
3
Matsuyama, Ehime, Japan, 790-8524
4
Fukuoka, Fukuoka, Japan, 813-0017