Dose-confirmatory Bridging Study in Total Knee Replacement

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01206972
First received: September 20, 2010
Last updated: July 15, 2013
Last verified: July 2013
  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.


Condition Intervention Phase
Venous Thromboembolism
Drug: Rivaroxaban (BAY59-7939)
Drug: Enoxaparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • deep vein thrombosis (total, proximal, distal) [ Time Frame: up to Day 13 (±2 days) ] [ Designated as safety issue: No ]
  • symptomatic venous thromboembolism [ Time Frame: up to Day 13 (±2 days) ] [ Designated as safety issue: No ]
  • major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death) [ Time Frame: up to Day 13 (±2 days) ] [ Designated as safety issue: No ]
  • symptomatic venous thromboembolism [ Time Frame: within 30 days after stop of treatment with study drug ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206972

Locations
Japan
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
Izumi, Osaka, Japan, 594-0071
Izumisano, Osaka, Japan, 598-8577
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, 819-8551
Fukuoka, Japan, 813-0017
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
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Ltd.
ClinicalTrials.gov Identifier: NCT01206972     History of Changes
Other Study ID Numbers: 14398
Study First Received: September 20, 2010
Last Updated: July 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
venous thromboembolism
prevention
orthopaedic surgery

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 16, 2014