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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00353678
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : March 21, 2013
Astellas Pharma Europe B.V.
Information provided by (Responsible Party):
Astellas Pharma Inc

July 18, 2006
July 19, 2006
March 21, 2013
June 2006
August 2007   (Final data collection date for primary outcome measure)
  • Rate of total venous thromboembolism (VTE) during hospitalization phase
  • Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
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Complete list of historical versions of study NCT00353678 on Archive Site
  • Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
  • Symptomatic VTE
  • Rate of total VTE
  • Death due to any cause during treatment
  • Incidence of the bleeding types:
  • Major or clinically relevant non-major bleeding, Major bleeding,
  • Clinically relevant non-major bleeding, Minor bleeding
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Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
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
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.
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Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Drug: YM150
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Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kälebo P, Wetherill G, Wilpshaar JW, Meems L; ONYX-2 STUDY GROUP. Prevention of venous thromboembolism with an oral factor Xa inhibitor, YM150, after total hip arthroplasty. A dose finding study (ONYX-2). J Thromb Haemost. 2010 Apr;8(4):714-21. doi: 10.1111/j.1538-7836.2010.03748.x. Epub 2010 Jan 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Austria,   Bosnia and Herzegovina,   Czech Republic,   Denmark,   Finland,   Germany,   Greece,   Italy,   Latvia,   Lithuania,   Norway,   Poland,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden
Former Serbia and Montenegro
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Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Europe B.V.
Principal Investigator: Astellas Pharma Europe B.V., Medical Clinical Development Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
Astellas Pharma Inc
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP