Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events - Full Text View

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( Melagatran/ximelagatran was withdrawn from the market and clinical development in February 2006 in the interest of patient safety. )

First Received: September 13, 2005 Last Updated: May 2, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00206089

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: Melagatran/Ximelagatran	Phase III

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement Surgery

Drug Information available for: Melagatran Ximelagatran

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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.

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:	August 2005
Study Completion Date:	October 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

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

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 National Clinical Trials Identifier (NCT ID):

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. Epub 2008 May 15.

Study ID Numbers:	D4003C00030
Study First Received:	September 13, 2005
Last Updated:	May 2, 2008
ClinicalTrials.gov Identifier:	NCT00206089 History of Changes
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

Study placed in the following topic categories:

Hip Fractures
Embolism and Thrombosis
Anticoagulants
Melagatran
Embolism
Fractures, Bone

Vascular Diseases
Ximelagatran
Thrombosis
Thromboembolism
Enoxaparin

Additional relevant MeSH terms:

Embolism and Thrombosis
Anticoagulants
Melagatran
Embolism
Therapeutic Uses
Hematologic Agents

Vascular Diseases
Cardiovascular Diseases
Ximelagatran
Pharmacologic Actions
Thrombosis
Thromboembolism

ClinicalTrials.gov processed this record on May 07, 2009