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

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ClinicalTrials.gov Identifier: NCT00206089
Recruitment Status : Terminated (Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.)
First Posted : September 21, 2005
Last Update Posted : November 15, 2010
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Thromboembolism Drug: EXANTA Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
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 Start Date : September 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: EXANTA
    Other Name: Melagatran/Ximelagatran


Primary Outcome Measures :
  1. Non-inferiority for the prevention of VTE or VTE related death

Secondary Outcome Measures :
  1. Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.
  2. Safety


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00206089


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Austria
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Graz, Austria
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Innsbruck, Austria
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Leoben, Austria
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Neunkirchen, Austria
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Neustadt, Austria
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St Johann in Tirol, Austria
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Wien, Austria
Belgium
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Denmark
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Herlev, Denmark
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Oys, Finland
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Mexico Distrito Federal, Mexico
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Lillehammer, Norway
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Oslo, Norway
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Stavanger, Norway
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Ålesund, Norway
Poland
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Biaystok, Poland
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Bydgoszcz, Poland
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Chojnice, Poland
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Od, Poland
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Portugal
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South Africa
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Sandton, South Africa
Spain
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Madrid, Spain
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Orense, Spain
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Santander, Spain
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Valencia, Spain
Sweden
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Boras, Sweden
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Falköping, Sweden
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Falun, Sweden
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Göteborg, Sweden
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Jönköping, Sweden
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Kalmar, Sweden
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Kungalv, Sweden
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Linköping, Sweden
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Lund, Sweden
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Mölndal, Sweden
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Skövde, Sweden
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Stockholm, Sweden
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Uddevalla, Sweden
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Uppsala, Sweden
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Örebro, Sweden
Switzerland
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Basel, Switzerland
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Bern, Switzerland
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Genève, Switzerland
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Lugano, Switzerland
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Luzem, Switzerland
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Zurich, Switzerland
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Medical Science Director, MD AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206089     History of Changes
Other Study ID Numbers: D4003C00030
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: November 15, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ximelagatran
Melagatran
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants