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

Primary Purpose

Thromboembolism

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
YM150
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 18, 2006
Last Updated
March 19, 2013
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT00353678
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Europe B.V.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
Keywords
Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1141 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
YM150
Primary Outcome Measure Information:
Title
Rate of total venous thromboembolism (VTE) during hospitalization phase
Title
Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major
Secondary Outcome Measure Information:
Title
Proximal or distal deep vein thrombosis (DVT) during hospitalization phase
Title
Symptomatic VTE
Title
Rate of total VTE
Title
Death due to any cause during treatment
Title
Incidence of the bleeding types:
Title
Major or clinically relevant non-major bleeding, Major bleeding,
Title
Clinically relevant non-major bleeding, Minor bleeding

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astellas Pharma Europe B.V., Medical Clinical Development
Organizational Affiliation
Department of Orthopedics, Surgical Sciences, Gothenburg University Sahlgrenska/ÖSTRA University Hospital, Goteborg, Sweden
Official's Role
Principal Investigator
Facility Information:
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
City
Vienna
ZIP/Postal Code
1130
Country
Austria
City
Foca
ZIP/Postal Code
73300
Country
Bosnia and Herzegovina
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
City
Brno
ZIP/Postal Code
66250
Country
Czech Republic
City
Kladno
ZIP/Postal Code
27259
Country
Czech Republic
City
Praha
ZIP/Postal Code
18000
Country
Czech Republic
City
Trebic
ZIP/Postal Code
67401
Country
Czech Republic
City
Copenhagen
ZIP/Postal Code
2300
Country
Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
City
Horsholm
ZIP/Postal Code
2970
Country
Denmark
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
City
Jyvaskyla
ZIP/Postal Code
40620
Country
Finland
City
Oulu
ZIP/Postal Code
90220
Country
Finland
City
Berlin
ZIP/Postal Code
12157
Country
Germany
City
Frankfurt am Main
ZIP/Postal Code
60528
Country
Germany
City
Halle
ZIP/Postal Code
06112
Country
Germany
City
Kremmen OT Somerfeld
ZIP/Postal Code
16766
Country
Germany
City
Markgroningen
ZIP/Postal Code
71706
Country
Germany
City
Schwandorf
ZIP/Postal Code
92421
Country
Germany
City
Athens
ZIP/Postal Code
166 73
Country
Greece
City
Melissia
ZIP/Postal Code
151 27
Country
Greece
City
Bologna
ZIP/Postal Code
40136
Country
Italy
City
Milano
ZIP/Postal Code
20123
Country
Italy
City
Milano
ZIP/Postal Code
20162
Country
Italy
City
Parma
ZIP/Postal Code
43100
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Pietra Ligure
ZIP/Postal Code
17027
Country
Italy
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
City
S. Donato Milanese
ZIP/Postal Code
20097
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Riga
ZIP/Postal Code
LV 1004
Country
Latvia
City
Riga
ZIP/Postal Code
LV 1005
Country
Latvia
City
Valmiera
ZIP/Postal Code
4201
Country
Latvia
City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
City
Vilnius
ZIP/Postal Code
LT-04130
Country
Lithuania
City
Elverum
ZIP/Postal Code
2409
Country
Norway
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
City
Tynset
ZIP/Postal Code
2500
Country
Norway
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
City
Lublin
ZIP/Postal Code
20-718
Country
Poland
City
Lublin
ZIP/Postal Code
20-951
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Chelyabinsk
ZIP/Postal Code
454026
Country
Russian Federation
City
Moscow
ZIP/Postal Code
111539
Country
Russian Federation
City
Moscow
ZIP/Postal Code
117869
Country
Russian Federation
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
City
Moscow
ZIP/Postal Code
129327
Country
Russian Federation
City
Nizhniy Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
City
St Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
City
Volgograd
ZIP/Postal Code
400040
Country
Russian Federation
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
City
Nis
ZIP/Postal Code
18000
Country
Serbia
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
City
Subotica
ZIP/Postal Code
24000
Country
Serbia
City
Banska Bysterica
ZIP/Postal Code
974 01
Country
Slovakia
City
Ruzomberok
ZIP/Postal Code
034 26
Country
Slovakia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
City
Cantoria
ZIP/Postal Code
39120
Country
Spain
City
Castellon
ZIP/Postal Code
12004
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28035
Country
Spain
City
Madrid
ZIP/Postal Code
28040
Country
Spain
City
Madrid
ZIP/Postal Code
28046
Country
Spain
City
Valencia
ZIP/Postal Code
46010
Country
Spain
City
Falkoping
ZIP/Postal Code
52185
Country
Sweden
City
Goteborg
ZIP/Postal Code
41685
Country
Sweden
City
Kalmar
ZIP/Postal Code
39185
Country
Sweden
City
Motala
ZIP/Postal Code
59185
Country
Sweden
City
Stockholm
ZIP/Postal Code
11883
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20088935
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.
Results Reference
background
Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=560
Description
Link to results on JAPIC

Learn more about this trial

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

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