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

This study has been terminated.
(Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety.)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206089
First received: September 13, 2005
Last updated: November 11, 2010
Last verified: November 2010
  Purpose

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 Intervention Phase
Thromboembolism
Drug: EXANTA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 3300
Study Start Date: September 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: EXANTA
    Other Name: Melagatran/Ximelagatran
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206089

  Show 125 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00206089     History of Changes
Other Study ID Numbers: D4003C00030
Study First Received: September 13, 2005
Last Updated: November 11, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Hip Fractures
Thromboembolism
Embolism
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Melagatran
Ximelagatran
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 18, 2014