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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00353678

Enrollment

1141

Registered

2006-07-19

Start date

2006-06-30

Completion date

2007-08-31

Last updated

2013-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip

Brief 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.

Interventions

DRUGYM150

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of total venous thromboembolism (VTE) during hospitalization phase	—
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major	—

Secondary

Measure	Time frame
Proximal or distal deep vein thrombosis (DVT) during hospitalization phase	—
Symptomatic VTE	—
Major or clinically relevant non-major bleeding, Major bleeding,	—
Death due to any cause during treatment	—
Incidence of the bleeding types:	—
Rate of total VTE	—
Clinically relevant non-major bleeding, Minor bleeding	—

Countries

Austria, Bosnia and Herzegovina, Czechia, Denmark, Finland, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Russia, Serbia, Slovakia, Spain, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026