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

Thromboembolism Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00353678
• Other study ID #: 150-CL-008
• Status: Completed
• Phase: Phase 2
• First received: July 18, 2006
• Last updated: March 19, 2013
• Start date: June 2006
• Est. completion date: August 2007

Study information

• Verified date: March 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBosnia: Ministry of Health and Social SecuritySerbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1141
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Drug:
• YM150

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Austria,  Bosnia and Herzegovina,  Czech Republic,  Denmark,  Finland,  Germany,  Greece,  Italy,  Latvia,  Lithuania,  Norway,  Poland,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of total venous thromboembolism (VTE) during hospitalization phase
Primary	Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
Secondary	Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
Secondary	Symptomatic VTE
Secondary	Rate of total VTE
Secondary	Death due to any cause during treatment
Secondary	Incidence of the bleeding types:
Secondary	Major or clinically relevant non-major bleeding, Major bleeding,
Secondary	Clinically relevant non-major bleeding, Minor bleeding

External Links

•   Link to results on JAPIC