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

NCT00353678 | Completed Phase 2

• 1 other identifier: 150-CL-008
• Study Type: interventional
• Target: 1,141
• Locations: 16 countries
• Sites: 74

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.

Conditions

Thromboembolism

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Rate of total venous thromboembolism (VTE) during hospitalization phase

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

Secondary Outcomes (7)

• 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:

Interventions

YM150 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Europe B.V.: collaborator

Study Sites (79)

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Vienna, 1130, Austria

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Foča, 73300, Bosnia and Herzegovina

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Sarajevo, 71000, Bosnia and Herzegovina

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Tuzla, 75000, Bosnia and Herzegovina

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Brno, 66250, Czechia

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Kladno, 27259, Czechia

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Prague, 18000, Czechia

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Třebíč, 67401, Czechia

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Copenhagen, 2300, Denmark

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Herlev, 2730, Denmark

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Hørsholm, 2970, Denmark

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Silkeborg, 8600, Denmark

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Jyväskylä, 40620, Finland

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Oulu, 90220, Finland

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Berlin, 12157, Germany

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Frankfurt am Main, 60528, Germany

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Halle, 06112, Germany

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Kremmen OT Somerfeld, 16766, Germany

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Markgröningen, 71706, Germany

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Schwandorf in Bayern, 92421, Germany

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Athens, 166 73, Greece

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Melíssia, 151 27, Greece

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Bologna, 40136, Italy

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Milan, 20123, Italy

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Milan, 20162, Italy

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Parma, 43100, Italy

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Pavia, 27100, Italy

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Pietra Ligure, 17027, Italy

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Reggio Emilia, 42100, Italy

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Rozzano, 20089, Italy

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S. Donato Milanese, 20097, Italy

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Udine, 33100, Italy

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Riga, LV 1004, Latvia

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Riga, LV 1005, Latvia

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Valmiera, 4201, Latvia

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Kaunas, LT-50009, Lithuania

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Vilnius, LT-04130, Lithuania

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Elverum, 2409, Norway

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Trondheim, 7006, Norway

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Tynset, 2500, Norway

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Bialystok, 15-276, Poland

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Katowice, 40-635, Poland

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Krakow, 31-826, Poland

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Lublin, 20-718, Poland

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Lublin, 20-951, Poland

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Warsaw, 00-909, Poland

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Chelyabinsk, 454026, Russia

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Moscow, 111539, Russia

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Moscow, 117869, Russia

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Moscow, 119049, Russia

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Moscow, 129327, Russia

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Nizhny Novgorod, 603155, Russia

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Orenburg, 460000, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 195067, Russia

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Samara, 443095, Russia

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Volgograd, 400040, Russia

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Belgrade, 11000, Serbia

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Kragujevac, 34000, Serbia

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Niš, 18000, Serbia

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Novi Sad, 21000, Serbia

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Subotica, 24000, Serbia

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Banska Bysterica, 974 01, Slovakia

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Ružomberok, 034 26, Slovakia

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Cantoria, 39120, Spain

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Castellon, 12004, Spain

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Cáceres, 10003, Spain

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Madrid, 28006, Spain

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Madrid, 28035, Spain

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Madrid, 28040, Spain

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Madrid, 28046, Spain

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Valencia, 46010, Spain

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Falköping, 52185, Sweden

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Gothenburg, 41685, Sweden

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Kalmar, 39185, Sweden

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Motala, 59185, Sweden

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Stockholm, 11883, Sweden

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Related Publications (1)

• 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.

  PMID: 20088935 BACKGROUND

MeSH Terms

Conditions

Thromboembolism

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Astellas Pharma Europe B.V., Medical Clinical Development

  Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2006
• First Posted: July 19, 2006
• Study Start: June 1, 2006
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 21, 2013

Record last verified: 2013-03

Locations

DE (6); BO (3); DK (4); PL (6); AU (3); LI (2); LA (3); FI (2); GR (2); CZ (4); NO (3); SL (2); RU (11); IT (10); SE (5); ES (8)