Dose-confirmatory Bridging Study in Total Knee 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 Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206972
• Other study ID #: 14398
• Status: Completed
• Phase: Phase 3
• First received: September 20, 2010
• Last updated: January 17, 2017
• Start date: October 2010
• Est. completion date: June 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: June 2011
• Est. primary completion date: May 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 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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Rivaroxaban (BAY59-7939)
daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
• Rivaroxaban (BAY59-7939)
daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
• Rivaroxaban (BAY59-7939)
daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
• Enoxaparin
daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Scientific Affairs, 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 13 (±2 days)
Primary	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
Secondary	deep vein thrombosis (total, proximal, distal)		up to Day 13 (±2 days)
Secondary	symptomatic venous thromboembolism		up to Day 13 (±2 days)
Secondary	major venous thromboembolism (proximal deep vein thromboembolism, pulmonary embolism or venous thromboembolism-related death)		up to Day 13 (±2 days)
Secondary	symptomatic venous thromboembolism		within 30 days after stop of treatment with study drug

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