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

Primary Purpose

Thromboembolism

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
EXANTA
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thromboembolism focused on measuring Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery

Eligibility Criteria

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

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.

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Outcomes

Primary Outcome Measures

Non-inferiority for the prevention of VTE or VTE related death

Secondary Outcome Measures

Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Safety

Full Information

First Posted
September 13, 2005
Last Updated
November 11, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206089
Brief Title
Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Terminated
Why Stopped
Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thromboembolism
Keywords
Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
3300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
EXANTA
Other Intervention Name(s)
Melagatran/Ximelagatran
Primary Outcome Measure Information:
Title
Non-inferiority for the prevention of VTE or VTE related death
Secondary Outcome Measure Information:
Title
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Graz
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Austria
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Innsbruck
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Austria
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Leoben
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Austria
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Neunkirchen
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Austria
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Neustadt
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Austria
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St Johann in Tirol
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Austria
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Viborg
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Austria
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Wels
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Austria
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Wien
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Austria
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Arhus
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Denmark
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Glostrup
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Denmark
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Hellerup
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Denmark
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Herlev
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Denmark
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Hillerod
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Denmark
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Holstebro
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Denmark
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Horsholm
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Denmark
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Hvidovre
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Denmark
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Silkeborg
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Denmark
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Vejle
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Denmark
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Hus
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Finland
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Jyvaskyla
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Finland
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Kuopio
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Finland
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Oys
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Finland
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Tampere
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Finland
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Turku
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Finland
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Amiens
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France
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Annecy
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France
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Caen
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France
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Creteil
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France
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Le Kremlin Bicetre
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France
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Montpellier
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France
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Nice Cedex 1
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France
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Paris
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France
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Saint Etienne
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France
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Bad Mergentheim
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Germany
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Dusseldorf
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Garmisch-Partenkirchen
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Germany
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Halle
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Germany
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Rheinfelden
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Germany
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Sommerfeld
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Germany
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Wiesbaden
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Germany
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Budapest
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Hungary
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Gyula
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Hungary
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Gyzr
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Hungary
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Kecskemet
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Hungary
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Pecs
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Szeged
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Hungary
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Székesthérvár
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Hungary
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Estado de Mexico
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Mexico
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Guadalajara
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Mexico
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Mexico Distrito Federal
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Mexico
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Assen
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Netherlands
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Breda
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Groningen
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Leeuwarden
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Sittard
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Zaandam
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Zwolle
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Netherlands
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Bergen
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Norway
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Bodo
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Drammen
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Elverum
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Gjettum
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Hagavik
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Kongsberg
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Norway
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Kongsvinger
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Larvik
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Levanger
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Lillehammer
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Nordbyhagen
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Oslo
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Skien
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Stavanger
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Trondheim
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Ålesund
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Norway
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Biaystok
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Poland
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Bydgoszcz
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Poland
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Chojnice
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Gdansk
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Od
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Wrocraw
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Barreiro
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Portugal
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Cascais
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Portugal
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Lisboa
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Portugal
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Parede
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Portugal
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Setúbal
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Portugal
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Torres Vedras
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Portugal
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Vila Franca de Xira
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Portugal
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Durban
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South Africa
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Gauteng
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South Africa
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Sandton
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South Africa
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Barcelona
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Spain
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Madrid
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Spain
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Orense
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Spain
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Santander
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Spain
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Valencia
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Spain
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Boras
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Sweden
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Falköping
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Sweden
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Falun
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Sweden
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Göteborg
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Sweden
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Jönköping
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Sweden
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Kalmar
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Sweden
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Kungalv
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Sweden
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Linköping
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Sweden
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Lund
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Sweden
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Mölndal
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Sweden
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Skövde
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Sweden
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Stockholm
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Sweden
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Uddevalla
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Sweden
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Uppsala
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Sweden
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Örebro
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Sweden
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Basel
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Switzerland
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Bern
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Switzerland
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Genève
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Switzerland
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Lugano
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Switzerland
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Luzem
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Switzerland
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Zurich
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Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
18485453
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.
Results Reference
derived

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

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