Dose-confirmatory Bridging Study in Total Knee Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01206972
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : January 18, 2017
Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2010
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement
Drug Information available for: Rivaroxaban
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Rivaroxaban (BAY59-7939)
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
Experimental: Arm 2 Drug: Rivaroxaban (BAY59-7939)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
Experimental: Arm 3 Drug: Rivaroxaban (BAY59-7939)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
Active Comparator: Arm 4 Drug: Enoxaparin
daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)

Primary Outcome Measures :
  1. 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) ]
  2. 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 ]

Secondary Outcome Measures :
  1. deep vein thrombosis (total, proximal, distal) [ Time Frame: up to Day 13 (±2 days) ]
  2. symptomatic venous thromboembolism [ Time Frame: up to Day 13 (±2 days) ]
  3. major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death) [ Time Frame: up to Day 13 (±2 days) ]
  4. symptomatic venous thromboembolism [ Time Frame: within 30 days after stop of treatment with study drug ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01206972

Nagoya, Aichi, Japan, 455-8530
Matsudo, Chiba, Japan, 271-8511
Matsuyama, Ehime, Japan, 790-8524
Kawanuma, Fukushima, Japan, 969-6593
Koriyama, Fukushima, Japan, 963-8501
Asahikawa, Hokkaido, Japan, 078-8237
Hakodate, Hokkaido, Japan, 040-8611
Sapporo, Hokkaido, Japan, 060-8648
Kakogawa, Hyogo, Japan, 675-8545
Kobe, Hyogo, Japan, 657-0068
Nishinomiya, Hyogo, Japan, 663-8501
Tsukuba, Ibaraki, Japan, 305-0854
Iida, Nagano, Japan, 395-8505
Sasebo, Nagasaki, Japan, 857-8575
Tomigusuku, Okinawa, Japan, 901-0243
Hirakata, Osaka, Japan, 573-8511
Izumisano, Osaka, Japan, 598-8577
Izumi, Osaka, Japan, 594-0071
Kishiwada, Osaka, Japan, 596-8501
Kishiwada, Osaka, Japan, 596-8522
Osakasayama, Osaka, Japan, 589-8511
Sakai, Osaka, Japan, 599-8271
Takatsuki, Osaka, Japan, 569-1192
Adachi, Tokyo, Japan, 121-0064
Nerima-ku, Tokyo, Japan, 177-8521
Fukuoka, Japan, 813-0017
Fukuoka, Japan, 819-8551
Kyoto, Japan, 602-8026
Osaka, Japan, 530-0012
Osaka, Japan, 558-8558
Saga, Japan, 849-8501
Saitama, Japan, 336-8522
Toyama, Japan, 930-8550
Sponsors and Collaborators
Janssen Scientific Affairs, LLC
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer Identifier: NCT01206972     History of Changes
Other Study ID Numbers: 14398
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017

Keywords provided by Bayer:
venous thromboembolism
orthopaedic surgery

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action