Clinical trial NCT00353678: Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thromboembolism
Keywords: Hip replacement
Arthroplasty
Prevention
Thromboembolism
Treatment outcomes
Arthroplasty, replacement, hip
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Europe B.V.
First posted: 2006-07-19
Enrollment: 1141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of total venous thromboembolism (VTE) during hospitalization phase
measure: Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
Secondary outcomes:
measure: Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
measure: Symptomatic VTE
measure: Rate of total VTE
measure: Death due to any cause during treatment
measure: Incidence of the bleeding types:
measure: Major or clinically relevant non-major bleeding, Major bleeding,
measure: Clinically relevant non-major bleeding, Minor bleeding
Other outcomes:
Locations:
city: Innsbruck
country: Austria
city: Vienna
country: Austria
city: Vienna
country: Austria
city: Foca
country: Bosnia and Herzegovina
city: Sarajevo
country: Bosnia and Herzegovina
city: Tuzla
country: Bosnia and Herzegovina
city: Brno
country: Czech Republic
city: Kladno
country: Czech Republic
city: Praha
country: Czech Republic
city: Trebic
country: Czech Republic
city: Copenhagen
country: Denmark
city: Herlev
country: Denmark
city: Horsholm
country: Denmark
city: Silkeborg
country: Denmark
city: Jyvaskyla
country: Finland
city: Oulu
country: Finland
city: Berlin
country: Germany
city: Frankfurt am Main
country: Germany
city: Halle
country: Germany
city: Kremmen OT Somerfeld
country: Germany
city: Markgroningen
country: Germany
city: Schwandorf
country: Germany
city: Athens
country: Greece
city: Melissia
country: Greece
city: Bologna
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Parma
country: Italy
city: Pavia
country: Italy
city: Pietra Ligure
country: Italy
city: Reggio Emilia
country: Italy
city: Rozzano
country: Italy
city: S. Donato Milanese
country: Italy
city: Udine
country: Italy
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Valmiera
country: Latvia
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Elverum
country: Norway
city: Trondheim
country: Norway
city: Tynset
country: Norway
city: Bialystok
country: Poland
city: Katowice
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Lublin
country: Poland
city: Warszawa
country: Poland
city: Chelyabinsk
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Nis
country: Serbia
city: Novi Sad
country: Serbia
city: Subotica
country: Serbia
city: Banska Bysterica
country: Slovakia
city: Ruzomberok
country: Slovakia
city: Caceres
country: Spain
city: Cantoria
country: Spain
city: Castellon
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Falkoping
country: Sweden
city: Goteborg
country: Sweden
city: Kalmar
country: Sweden
city: Motala
country: Sweden
city: Stockholm
country: Sweden
Study officials:
affiliation: Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
name: Astellas Pharma Europe B.V., Medical Clinical Development
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eriksson BI, Turpie AG, Lassen MR, Prins MH, Agnelli G, Kalebo 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.