check_circleStudy Completed

Venous thromboembolism

Bayer Identifier:

14398

ClinicalTrials.gov Identifier:

NCT01206972

EudraCT Number:

Not Available

EU CT Number:

Not Available
Dose-confirmatory bridging study in total knee replacement

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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
  • - 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
October 2010 - June 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Asahikawa, 078-8237, Japan
Completed
Hakodate, 040-8611, Japan
Completed
Koriyama, 963-8501, Japan
Completed
Kawanuma, 969-6593, Japan
Completed
Tsukuba, 305-0854, Japan
Completed
Saitama, 336-8522, Japan
Completed
Matsudo, 271-8511, Japan
Completed
Nerima-ku, 177-8521, Japan
Completed
Adachi, 121-0064, Japan
Completed
Iida, 395-8505, Japan
Completed
Nagoya, 455-8530, Japan
Completed
Kyoto, 602-8026, Japan
Completed
Osaka, 530-0012, Japan
Completed
Osaka, 558-8558, Japan
Completed
Takatsuki, 569-1192, Japan
Completed
Hirakata, 573-8511, Japan
Completed
Sakai, 599-8271, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Kishiwada, 596-8522, Japan
Completed
Kishiwada, 596-8501, Japan
Completed
Izumisano, 598-8577, Japan
Completed
Izumi, 594-0071, Japan
Completed
Kobe, 657-0068, Japan
Completed
Nishinomiya, 663-8501, Japan
Completed
Kakogawa, 675-8545, Japan
Completed
Fukuoka, 813-0017, Japan
Completed
Fukuoka, 819-8551, Japan
Completed
Saga, 849-8501, Japan
Completed
Sasebo, 857-8575, Japan
Completed
Tomigusuku, 901-0243, Japan
Completed
Toyama, 930-8550, Japan
Completed
Matsuyama, 790-8524, Japan
Completed
Sapporo, 060-8648, Japan

Primary Outcome

  • A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes
    date_rangeTime Frame:
    up to Day 13 (±2 days)
    enhanced_encryption
    Safety Issue:
    No
  • Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)
    date_rangeTime Frame:
    from the first intake of study medication to no later than 2 days after the last intake of study drug
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • deep vein thrombosis (total, proximal, distal)
    date_rangeTime Frame:
    up to Day 13 (±2 days)
    enhanced_encryption
    Safety Issue:
    No
  • symptomatic venous thromboembolism
    date_rangeTime Frame:
    up to Day 13 (±2 days)
    enhanced_encryption
    Safety Issue:
    No
  • major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)
    date_rangeTime Frame:
    up to Day 13 (±2 days)
    enhanced_encryption
    Safety Issue:
    No
  • symptomatic venous thromboembolism
    date_rangeTime Frame:
    within 30 days after stop of treatment with study drug
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.