Dose-confirmatory Bridging Study in Total Knee Replacement

NCT01206972 | Completed Phase 3

• 1 other identifier: 14398
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 33

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.

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism; prevention; orthopaedic surgery

Outcome Measures

Primary Outcomes (2)

• A composite endpoint of any deep vein thrombosis (proximal and/or distal), non-fatal pulmonary embolism and death from all causes

  up to Day 13 (±2 days)

• Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)

  from the first intake of study medication to no later than 2 days after the last intake of study drug

Secondary Outcomes (4)

• deep vein thrombosis (total, proximal, distal)

  up to Day 13 (±2 days)

• symptomatic venous thromboembolism

  up to Day 13 (±2 days)

• major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)

  up to Day 13 (±2 days)

• symptomatic venous thromboembolism

  within 30 days after stop of treatment with study drug

Study Arms (4)

Arm 1

EXPERIMENTAL

Drug: Rivaroxaban (BAY59-7939)

Arm 2

EXPERIMENTAL

Drug: Rivaroxaban (BAY59-7939)

Arm 3

EXPERIMENTAL

Drug: Rivaroxaban (BAY59-7939)

Arm 4

ACTIVE COMPARATOR

Drug: Enoxaparin

Interventions

Rivaroxaban (BAY59-7939) DRUG

daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)

Arm 1

Enoxaparin DRUG

daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)

Arm 4

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Janssen Scientific Affairs, LLC: collaborator

Study Sites (33)

Unknown Facility

Nagoya, Aichi-ken, 455-8530, Japan

Location

Unknown Facility

Matsudo, Chiba, 271-8511, Japan

Location

Unknown Facility

Matsuyama, Ehime, 790-8524, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 813-0017, Japan

Location

Unknown Facility

Fukuoka, Fukuoka, 819-8551, Japan

Location

Unknown Facility

Kawanuma, Fukushima, 969-6593, Japan

Location

Unknown Facility

Kōriyama, Fukushima, 963-8501, Japan

Location

Unknown Facility

Asahikawa, Hokkaido, 078-8237, Japan

Location

Unknown Facility

Hakodate, Hokkaido, 040-8611, Japan

Location

Unknown Facility

Sapporo, Hokkaido, 060-8648, Japan

Location

Unknown Facility

Kakogawa, Hyōgo, 675-8545, Japan

Location

Unknown Facility

Kobe, Hyōgo, 657-0068, Japan

Location

Unknown Facility

Nishinomiya, Hyōgo, 663-8501, Japan

Location

Unknown Facility

Tsukuba, Ibaraki, 305-0854, Japan

Location

Unknown Facility

Kyoto, Kyoto, 602-8026, Japan

Location

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Iida, Nagano, 395-8505, Japan

Location

Unknown Facility

Sasebo, Nagasaki, 857-8575, Japan

Location

Unknown Facility

Tomigusuku, Okinawa, 901-0243, Japan

Location

Unknown Facility

Hirakata, Osaka, 573-8511, Japan

Location

Unknown Facility

Izumi, Osaka, 594-0071, Japan

Location

Unknown Facility

Izumisano, Osaka, 598-8577, Japan

Location

Unknown Facility

Kishiwada, Osaka, 596-8501, Japan

Location

Unknown Facility

Kishiwada, Osaka, 596-8522, Japan

Location

Unknown Facility

Osaka, Osaka, 530-0012, Japan

Location

Unknown Facility

Osaka, Osaka, 558-8558, Japan

Location

Unknown Facility

Sakai, Osaka, 599-8271, Japan

Location

Unknown Facility

Sayama, Osaka, 589-8511, Japan

Location

Unknown Facility

Takatsuki, Osaka, 569-1192, Japan

Location

Unknown Facility

Saga, Saga-ken, 849-8501, Japan

Location

Unknown Facility

Saitama, Saitama, 336-8522, Japan

Location

Unknown Facility

Adachi City, Tokyo, 121-0064, Japan

Location

Unknown Facility

Nerima-ku, Tokyo, 177-8521, Japan

Location

Unknown Facility

Toyama, Toyama, 930-8550, Japan

Location

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rivaroxaban; Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2010
• First Posted: September 22, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 18, 2017

Record last verified: 2017-01

Locations

JP (33)