Dose-confirmatory Bridging Study in Total Hip Replacement

NCT01205932 | Completed Phase 3

• 1 other identifier: 14397
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 41

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 hip replacement (THR) and to confirm the extrapolability of global data to Japanese patients by comparing with data from overseas phase II study (ODIXa-OD.HIP - Study 11527).

Conditions

Venous Thromboembolism

Keywords

venous thromboembolism; prevention; othopaedic 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 9 (±2 days)

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

  Up to Day 8 (±2 days)

Secondary Outcomes (6)

• Deep vein thrombosis (total, proximal, distal)

  up to Day 9 (±2 days)

• Symptomatic venous thromboembolism

  up to Day 9 (±2 days)

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

  up to Day 9 (±2 days)

• Symptomatic venous thromboembolism

  up to Day 36 (±4 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 34 to 35 days (±4 days)

Arm 1

Enoxaparin DRUG

daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 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 THR (the first replacement of the applicable hip 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 THR 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 THR 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 Research & Development, LLC: collaborator

Study Sites (41)

Unknown Facility

Nagoya, Aichi-ken, 455-8530, Japan

Location

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Matsudo, Chiba, 271-8511, Japan

Location

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Narashino, Chiba, 275-8580, Japan

Location

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Matsuyama, Ehime, 790-8524, Japan

Location

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Fukuoka, Fukuoka, 813-0017, Japan

Location

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Fukuoka, Fukuoka, 814-8525, Japan

Location

Unknown Facility

Kōriyama, Fukushima, 963-8501, Japan

Location

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Asahikawa, Hokkaido, 078-8237, Japan

Location

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Hakodate, Hokkaido, 040-8611, Japan

Location

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Sapporo, Hokkaido, 060-8648, Japan

Location

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Kakogawa, Hyōgo, 675-8545, Japan

Location

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Kobe, Hyōgo, 657-0068, Japan

Location

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Nishinomiya, Hyōgo, 663-8501, Japan

Location

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Tsukuba, Ibaraki, 305-0854, Japan

Location

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Kagoshima, Kagoshima-ken, 890-0014, Japan

Location

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Kamakura, Kanagawa, 247-0061, Japan

Location

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Yokohama, Kanagawa, 236-0004, Japan

Location

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Kumamoto, Kumamoto, 862-8505, Japan

Location

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Kyoto, Kyoto, 602-8026, Japan

Location

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Iida, Nagano, 395-8505, Japan

Location

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Sasebo, Nagasaki, 857-0135, Japan

Location

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Sasebo, Nagasaki, 857-8575, Japan

Location

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Kurashiki, Okayama-ken, 710-8522, Japan

Location

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Tomigusuku, Okinawa, 901-0243, Japan

Location

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Hirakata, Osaka, 573-1191, Japan

Location

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Hirakata, Osaka, 573-8511, Japan

Location

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Izumi, Osaka, 594-0071, Japan

Location

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Izumisano, Osaka, 598-8577, Japan

Location

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Kishiwada, Osaka, 596-8501, Japan

Location

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Kishiwada, Osaka, 596-8522, Japan

Location

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Osaka, Osaka, 530-0012, Japan

Location

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Osaka, Osaka, 553-0003, Japan

Location

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Osaka, Osaka, 558-8558, Japan

Location

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Sakai, Osaka, 599-8271, Japan

Location

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Sayama, Osaka, 589-8511, Japan

Location

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Suita, Osaka, 564-0082, Japan

Location

Unknown Facility

Takatsuki, Osaka, 569-1192, Japan

Location

Unknown Facility

Saga, Saga-ken, 849-8501, Japan

Location

Unknown Facility

Nerima-ku, Tokyo, 177-8521, Japan

Location

Unknown Facility

Setagaya City, Tokyo, 158-0095, 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 19, 2010
• First Posted: September 21, 2010
• Study Start: September 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 23, 2017

Record last verified: 2017-01

Locations

JP (41)