Trial Condition(s):

Venous Thromboembolism

Dose-confirmatory bridging study in total knee replacement

Bayer Identifier:

14398

ClinicalTrials.gov Identifier:

NCT01206972

EudraCT Number:

Not Available

Study Completed

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
302
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Asahikawa, Japan, 078-8237

Status
Completed
 
Locations

Investigative Site

Hakodate, Japan, 040-8611

Status
Completed
 
Locations

Investigative Site

Koriyama, Japan, 963-8501

Status
Completed
 
Locations

Investigative Site

Kawanuma, Japan, 969-6593

Status
Completed
 
Locations

Investigative Site

Tsukuba, Japan, 305-0854

Status
Completed
 
Locations

Investigative Site

Saitama, Japan, 336-8522

Status
Completed
 
Locations

Investigative Site

Matsudo, Japan, 271-8511

Status
Completed
 
Locations

Investigative Site

Nerima-ku, Japan, 177-8521

Status
Completed
 
Locations

Investigative Site

Adachi, Japan, 121-0064

Status
Completed
 
Locations

Investigative Site

Iida, Japan, 395-8505

Status
Completed
 
Locations

Investigative Site

Nagoya, Japan, 455-8530

Status
Completed
 
Locations

Investigative Site

Kyoto, Japan, 602-8026

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 530-0012

Status
Completed
 
Locations

Investigative Site

Osaka, Japan, 558-8558

Status
Completed
 
Locations

Investigative Site

Takatsuki, Japan, 569-1192

Status
Completed
 
Locations

Investigative Site

Hirakata, Japan, 573-8511

Status
Completed
 
Locations

Investigative Site

Sakai, Japan, 599-8271

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Kishiwada, Japan, 596-8522

Status
Completed
 
Locations

Investigative Site

Kishiwada, Japan, 596-8501

Status
Completed
 
Locations

Investigative Site

Izumisano, Japan, 598-8577

Status
Completed
 
Locations

Investigative Site

Izumi, Japan, 594-0071

Status
Completed
 
Locations

Investigative Site

Kobe, Japan, 657-0068

Status
Completed
 
Locations

Investigative Site

Nishinomiya, Japan, 663-8501

Status
Completed
 
Locations

Investigative Site

Kakogawa, Japan, 675-8545

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 813-0017

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 819-8551

Status
Completed
 
Locations

Investigative Site

Saga, Japan, 849-8501

Status
Completed
 
Locations

Investigative Site

Sasebo, Japan, 857-8575

Status
Completed
 
Locations

Investigative Site

Tomigusuku, Japan, 901-0243

Status
Completed
 
Locations

Investigative Site

Toyama, Japan, 930-8550

Status
Completed
 
Locations

Investigative Site

Matsuyama, Japan, 790-8524

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 060-8648

Status
Completed
 

Trial Design