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Completed

NCT Number: NCT00332020

Regulation of Coagulation in Orthopedic Surgery to Prevent DVT and PE, a Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Total Hip Replacement

The purpose of this study is to assess if 10 mg BAY 59-7939, taken once daily as a tablet, is safe and can help prevent blood clots forming after a hip replacement operation.

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Key information

Conditions

Prevention Cardiovascular Diseases Embolism and Thrombosis Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra, Australian Capital Territory, Australia

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 18 years or above
  • Patients scheduled for elective total hip replacement

Exclusion criteria

  • Planned, staged total bilateral hip replacement
  • Active bleeding or high risk of bleeding contraindicating treatment with low molecular weight heparin
  • Contraindication listed in the labeling or conditions precluding patient treatment with enoxaparin
  • Conditions prohibiting bilateral venography (e.g. amputation of one leg, allergy to contrast media)

Treatment and study plan

Rivaroxaban (BAY59-7939)

Drug

10 mg rivaroxaban (tablet) once daily administered for 35 +/- 4 days

Enoxaparin

Drug

40 mg enoxaparin syringe administered for 12 +/- 2 days

Primary outcomes

  1. Composite endpoint of total VTE i.e.: Any DVT (proximal and/or distal), Non fatal PE, Death of all causes

    Time frame: Treatment period: up to day 35+/-6

Secondary outcomes

  1. Incidence of the composite endpoint comprising proximal DVT, non-fatal PE and VTE- related death (major VTE)

    Time frame: Treatment period: up to day 35+/-6

  2. Incidence of symptomatic VTE (DVT, PE)

    Time frame: Treatment period: up to day 35+/-6

  3. Incidence of DVT (total, proximal, distal)

    Time frame: Treatment period: up to day 35+/-6

  4. Incidence of symptomatic VTE during follow-up

    Time frame: Follow-up period: following 35+/-6 days

  5. The composite endpoint comprising major VTE and treatment-emergent major bleeding

    Time frame: For major VTE, treatment period: up to Day 35+/-6 ; for major bleeding, from first dose of double-blind study medication to up to two days after last dose of double-blind study medication

  6. Incidence of the composite endpoint that results from the primary endpoint by substituting VTE related death for all death

    Time frame: Treatment period: up to day 35+/-6

  7. Incidence of the composite endpoint that results from major VTE by substituting all cause mortality for VTE-related death

    Time frame: Treatment period: up to day 35+/-6

  8. Treatment-emergent major bleedings

    Time frame: From first dose of double-blind study medication to up to two days after last dose of double-blind study medication

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

RECORD 2 Study: REgulation of Coagulation in ORthopedic Surgery to Prevent DVT and PE, Controlled, Double-blind, Randomized Study of BAY 59-7939 in the Extended Prevention of VTE in Patients Undergoing Elective Hip Replacement.

Acronym: RECORD 2

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
May 31, 2006
Registry last updated
Jan 27, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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