Dose-confirmatory Bridging Study in Total Knee Replacement

Phase 3

Completed

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

• Registration Number: NCT01206972
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-22
• Study Start: 2010-10
• Primary Completion: 2011-05
• Study Completion: 2011-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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
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)

Secondary Outcome Measures

Name	Time	Method
deep vein thrombosis (total, proximal, distal)	up to Day 13 (±2 days)
symptomatic venous thromboembolism	within 30 days after stop of treatment with study drug
major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)	up to Day 13 (±2 days)