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Completed

NCT Number: NCT01205932

Dose-confirmatory Bridging Study in Total Hip Replacement

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).

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban (BAY59-7939)

Drug

Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)

Enoxaparin

Drug

daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 21, 2010
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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