Clinical trial NCT00206089: Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Thromboembolism
Keywords: Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 3300
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: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Non-inferiority for the prevention of VTE or VTE related death
Secondary outcomes:
measure: Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
measure: Safety
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Neunkirchen
country: Austria
facility: Research Site
city: Neustadt
country: Austria
facility: Research Site
city: St Johann in Tirol
country: Austria
facility: Research Site
city: Viborg
country: Austria
facility: Research Site
city: Wels
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Arhus
country: Denmark
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Herlev
country: Denmark
facility: Research Site
city: Hillerod
country: Denmark
facility: Research Site
city: Holstebro
country: Denmark
facility: Research Site
city: Horsholm
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Silkeborg
country: Denmark
facility: Research Site
city: Vejle
country: Denmark
facility: Research Site
city: Hus
country: Finland
facility: Research Site
city: Jyvaskyla
country: Finland
facility: Research Site
city: Kuopio
country: Finland
facility: Research Site
city: Oys
country: Finland
facility: Research Site
city: Tampere
country: Finland
facility: Research Site
city: Turku
country: Finland
facility: Research Site
city: Amiens
country: France
facility: Research Site
city: Annecy
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Creteil
country: France
facility: Research Site
city: Le Kremlin Bicetre
country: France
facility: Research Site
city: Montpellier
country: France
facility: Research Site
city: Nice Cedex 1
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Saint Etienne
country: France
facility: Research Site
city: Bad Mergentheim
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Garmisch-Partenkirchen
country: Germany
facility: Research Site
city: Halle
country: Germany
facility: Research Site
city: Rheinfelden
country: Germany
facility: Research Site
city: Sommerfeld
country: Germany
facility: Research Site
city: Wiesbaden
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Gyula
country: Hungary
facility: Research Site
city: Gyzr
country: Hungary
facility: Research Site
city: Kecskemet
country: Hungary
facility: Research Site
city: Pecs
country: Hungary
facility: Research Site
city: Szeged
country: Hungary
facility: Research Site
city: Székesthérvár
country: Hungary
facility: Research Site
city: Estado de Mexico
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Mexico Distrito Federal
country: Mexico
facility: Research Site
city: Assen
country: Netherlands
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Hilversum
country: Netherlands
facility: Research Site
city: Leeuwarden
country: Netherlands
facility: Research Site
city: Sittard
country: Netherlands
facility: Research Site
city: Zaandam
country: Netherlands
facility: Research Site
city: Zwolle
country: Netherlands
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Bodo
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Gjettum
country: Norway
facility: Research Site
city: Hagavik
country: Norway
facility: Research Site
city: Kongsberg
country: Norway
facility: Research Site
city: Kongsvinger
country: Norway
facility: Research Site
city: Larvik
country: Norway
facility: Research Site
city: Levanger
country: Norway
facility: Research Site
city: Lillehammer
country: Norway
facility: Research Site
city: Nordbyhagen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Ålesund
country: Norway
facility: Research Site
city: Biaystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chojnice
country: Poland
facility: Research Site
city: Gdansk
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Od
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wrocraw
country: Poland
facility: Research Site
city: Barreiro
country: Portugal
facility: Research Site
city: Cascais
country: Portugal
facility: Research Site
city: Lisboa
country: Portugal
facility: Research Site
city: Parede
country: Portugal
facility: Research Site
city: Setúbal
country: Portugal
facility: Research Site
city: Torres Vedras
country: Portugal
facility: Research Site
city: Vila Franca de Xira
country: Portugal
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Gauteng
country: South Africa
facility: Research Site
city: Sandton
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Orense
country: Spain
facility: Research Site
city: Santander
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Boras
country: Sweden
facility: Research Site
city: Falköping
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Jönköping
country: Sweden
facility: Research Site
city: Kalmar
country: Sweden
facility: Research Site
city: Kungalv
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Mölndal
country: Sweden
facility: Research Site
city: Skövde
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bern
country: Switzerland
facility: Research Site
city: Genève
country: Switzerland
facility: Research Site
city: Lugano
country: Switzerland
facility: Research Site
city: Luzem
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Agnelli G, Eriksson BI, Cohen AT, Bergqvist D, Dahl OE, Lassen MR, Mouret P, Rosencher N, Andersson M, Bylock A, Jensen E, Boberg B; EXTEND Study Group. Safety assessment of new antithrombotic agents: lessons from the EXTEND study on ximelagatran. Thromb Res. 2009;123(3):488-97. doi: 10.1016/j.thromres.2008.02.017. Epub 2008 May 15.