Skip to main content
OpenTrials
Completed

NCT Number: NCT00353678

Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innsbruck, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled for elective primary hip replacement
  • Age 18 years or over
  • Written informed consent obtained

Exclusion criteria

  • Documented history or considered at increased risk of venous thromboembolism
  • Subjects considered at increased risk of bleeding
  • Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment
  • Concomitant use of anticoagulants/ antiplatelet agents

Treatment and study plan

YM150

Drug

Primary outcomes

  1. Rate of total venous thromboembolism (VTE) during hospitalization phase

  2. Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major

Secondary outcomes

  1. Proximal or distal deep vein thrombosis (DVT) during hospitalization phase

  2. Symptomatic VTE

  3. Rate of total VTE

  4. Death due to any cause during treatment

  5. Incidence of the bleeding types:

  6. Major or clinically relevant non-major bleeding, Major bleeding,

  7. Clinically relevant non-major bleeding, Minor bleeding

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Europe B.V.

Registry information

Official study title

Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 19, 2006
Registry last updated
Mar 21, 2013

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.