Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events

Thromboembolism Clinical Trial

— EXTEND  

Official title:

The "EXTEND" Study: A Randomized, Double-blind, Parallel-group, Phase III b, Multi-centre Study Evaluating Extended Prophylactic Treatment With Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events in Patients Undergoing Elective Hip Replacement or Hip Fracture Surgery.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00206089
• Other study ID #: D4003C00030
• Status: Terminated
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 11, 2010
• Start date: September 2005
• Est. completion date: August 2006

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being carried out to study the efficacy and safety of treatment with melagatran injection followed by ximelagatran tablets in preventing blood clots, compared with enoxaparin for a period of 5-6 weeks. A separate visit, independent from the study will be done approximately 6 months after the surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3300
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent,

• Female or male aged 18 years and over

• Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture.

Exclusion Criteria:

• History of heparin-induced thrombocytopenia

• Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency.

• Myocardial infarction, Ischemic stroke or Transient Ischemic Attack (TIA), systemic embolism or venous thrombo-embolism within 30 days of enrollment.

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:
• EXANTA

Locations

Country	Name	City	State
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Leoben
Austria	Research Site	Neunkirchen
Austria	Research Site	Neustadt
Austria	Research Site	St Johann in Tirol
Austria	Research Site	Viborg
Austria	Research Site	Wels
Austria	Research Site	Wien
Belgium	Research Site	Brussels
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Denmark	Research Site	Arhus
Denmark	Research Site	Glostrup
Denmark	Research Site	Hellerup
Denmark	Research Site	Herlev
Denmark	Research Site	Hillerod
Denmark	Research Site	Holstebro
Denmark	Research Site	Horsholm
Denmark	Research Site	Hvidovre
Denmark	Research Site	Silkeborg
Denmark	Research Site	Vejle
Finland	Research Site	Hus
Finland	Research Site	Jyvaskyla
Finland	Research Site	Kuopio
Finland	Research Site	Oys
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Amiens
France	Research Site	Annecy
France	Research Site	Caen
France	Research Site	Creteil
France	Research Site	Le Kremlin Bicetre
France	Research Site	Montpellier
France	Research Site	Nice Cedex 1
France	Research Site	Paris
France	Research Site	Saint Etienne
Germany	Research Site	Bad Mergentheim
Germany	Research Site	Dusseldorf
Germany	Research Site	Essen
Germany	Research Site	Frankfurt
Germany	Research Site	Garmisch-Partenkirchen
Germany	Research Site	Halle
Germany	Research Site	Rheinfelden
Germany	Research Site	Sommerfeld
Germany	Research Site	Wiesbaden
Hungary	Research Site	Budapest
Hungary	Research Site	Gyula
Hungary	Research Site	Gyzr
Hungary	Research Site	Kecskemet
Hungary	Research Site	Pecs
Hungary	Research Site	Szeged
Hungary	Research Site	Székesthérvár
Mexico	Research Site	Estado de Mexico
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mexico Distrito Federal
Netherlands	Research Site	Assen
Netherlands	Research Site	Breda
Netherlands	Research Site	Groningen
Netherlands	Research Site	Hilversum
Netherlands	Research Site	Leeuwarden
Netherlands	Research Site	Sittard
Netherlands	Research Site	Zaandam
Netherlands	Research Site	Zwolle
Norway	Research Site	Ålesund
Norway	Research Site	Bergen
Norway	Research Site	Bodo
Norway	Research Site	Drammen
Norway	Research Site	Elverum
Norway	Research Site	Gjettum
Norway	Research Site	Hagavik
Norway	Research Site	Kongsberg
Norway	Research Site	Kongsvinger
Norway	Research Site	Larvik
Norway	Research Site	Levanger
Norway	Research Site	Lillehammer
Norway	Research Site	Nordbyhagen
Norway	Research Site	Oslo
Norway	Research Site	Skien
Norway	Research Site	Stavanger
Norway	Research Site	Trondheim
Poland	Research Site	Biaystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Chojnice
Poland	Research Site	Gdansk
Poland	Research Site	Lublin
Poland	Research Site	Od
Poland	Research Site	Warszawa
Poland	Research Site	Wrocraw
Portugal	Research Site	Barreiro
Portugal	Research Site	Cascais
Portugal	Research Site	Lisboa
Portugal	Research Site	Parede
Portugal	Research Site	Setúbal
Portugal	Research Site	Torres Vedras
Portugal	Research Site	Vila Franca de Xira
South Africa	Research Site	Durban
South Africa	Research Site	Gauteng
South Africa	Research Site	Sandton
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Orense
Spain	Research Site	Santander
Spain	Research Site	Valencia
Sweden	Research Site	Boras
Sweden	Research Site	Falköping
Sweden	Research Site	Falun
Sweden	Research Site	Göteborg
Sweden	Research Site	Jönköping
Sweden	Research Site	Kalmar
Sweden	Research Site	Kungalv
Sweden	Research Site	Linköping
Sweden	Research Site	Lund
Sweden	Research Site	Mölndal
Sweden	Research Site	Örebro
Sweden	Research Site	Skövde
Sweden	Research Site	Stockholm
Sweden	Research Site	Uddevalla
Sweden	Research Site	Uppsala
Switzerland	Research Site	Basel
Switzerland	Research Site	Bern
Switzerland	Research Site	Genève
Switzerland	Research Site	Lugano
Switzerland	Research Site	Luzem
Switzerland	Research Site	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Finland,  France,  Germany,  Hungary,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  South Africa,  Spain,  Sweden,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority for the prevention of VTE or VTE related death
Secondary	Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Secondary	Safety