Dose-confirmatory Bridging Study in Total Hip Replacement

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Enoxaparin; Drug: Rivaroxaban (BAY59-7939)

• Registration Number: NCT01205932
• Lead Sponsor: Bayer

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-19
• Study First Submitted QC: 2010-09-19
• Study First Posted: 2010-09-21
• Primary Completion: 2011-06
• Study Completion: 2011-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-20
• Last Update Posted: 2017-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Enoxaparin	-
Arm 3	Rivaroxaban (BAY59-7939)	-
Arm 1	Rivaroxaban (BAY59-7939)	-
Arm 2	Rivaroxaban (BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Deep vein thrombosis (total, proximal, distal)	up to Day 9 (±2 days)
Symptomatic venous thromboembolism	within 30 days after stop of treatment with study drug.
Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death)	up to Day 9 (±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