Dose-confirmatory Bridging Study in Total Hip Replacement

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01205932
• Other study ID #: 14397
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2010
• Last updated: January 20, 2017
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: January 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (BAY59-7939)
Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
• Rivaroxaban (BAY59-7939)
Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
• Rivaroxaban (BAY59-7939)
Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
• Enoxaparin
daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Treatment-emergent bleeding (major, non-major clinically relevant, other non-major)		Up to Day 8 (±2 days)
Secondary	Deep vein thrombosis (total, proximal, distal)		up to Day 9 (±2 days)
Secondary	Symptomatic venous thromboembolism		up to Day 9 (±2 days)
Secondary	Major venous thromboembolism (proximal deep vein thrombosis, pulmonary embolism or venous thromboembolism-related death)		up to Day 9 (±2 days)
Secondary	Symptomatic venous thromboembolism		up to Day 36 (±4 days)
Secondary	Symptomatic venous thromboembolism		within 30 days after stop of treatment with study drug.
Secondary	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

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