Dose-confirmatory Bridging Study in Total Hip Replacement

• ClinicalTrials.gov Identifier: NCT01205932
• Recruitment Status: Completed
• First Posted: September 21, 2010
• Last Update Posted: January 23, 2017
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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).

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 402 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 Hip Replacement
• Study Start Date: September 2010
• Actual Primary Completion Date: June 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1	Drug: Rivaroxaban (BAY59-7939); Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
Experimental: Arm 2	Drug: Rivaroxaban (BAY59-7939); Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
Experimental: Arm 3	Drug: Rivaroxaban (BAY59-7939); Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
Active Comparator: Arm 4	Drug: Enoxaparin; daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)

Outcome Measures

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 9 (±2 days) ]
2. Treatment-emergent bleeding (major, non-major clinically relevant, other non-major) [ Time Frame: Up to Day 8 (±2 days) ]

Secondary Outcome Measures :

1. Deep vein thrombosis (total, proximal, distal) [ Time Frame: up to Day 9 (±2 days) ]
2. Symptomatic venous thromboembolism [ Time Frame: up to Day 9 (±2 days) ]
3. Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death) [ Time Frame: up to Day 9 (±2 days) ]
4. Symptomatic venous thromboembolism [ Time Frame: up to Day 36 (±4 days) ]
5. Symptomatic venous thromboembolism [ Time Frame: within 30 days after stop of treatment with study drug. ]
6. 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 ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

Japan

Nagoya, Aichi, Japan, 455-8530

Matsudo, Chiba, Japan, 271-8511

Narashino, Chiba, Japan, 275-8580

Matsuyama, Ehime, Japan, 790-8524

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

Kamakura, Kanagawa, Japan, 247-0061

Yokohama, Kanagawa, Japan, 236-0004

Iida, Nagano, Japan, 395-8505

Sasebo, Nagasaki, Japan, 857-0135

Sasebo, Nagasaki, Japan, 857-8575

Kurashiki, Okayama, Japan, 710-8522

Tomigusuku, Okinawa, Japan, 901-0243

Hirakata, Osaka, Japan, 573-1191

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

Suita, Osaka, Japan, 564-0082

Takatsuki, Osaka, Japan, 569-1192

Nerima-ku, Tokyo, Japan, 177-8521

Setagaya, Tokyo, Japan, 158-0095

Fukuoka, Japan, 813-0017

Fukuoka, Japan, 814-8525

Kagoshima, Japan, 890-0014

Kumamoto, Japan, 862-8505

Kyoto, Japan, 602-8026

Osaka, Japan, 530-0012

Osaka, Japan, 553-0003

Osaka, Japan, 558-8558

Saga, Japan, 849-8501

Toyama, Japan, 930-8550

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01205932
• Other Study ID Numbers: 14397
• First Posted: September 21, 2010
• Last Update Posted: January 23, 2017
• Last Verified: January 2017

Keywords provided by Bayer:

venous thromboembolism; prevention; othopaedic surgery

Additional relevant MeSH terms:

Thromboembolism; Venous Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Enoxaparin; Rivaroxaban; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents