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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206089

Acronym

EXTEND

Enrollment

3300

Registered

2005-09-21

Start date

2005-09-30

Completion date

2006-08-31

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism

Keywords

Prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery

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.

Interventions

DRUGEXANTA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Non-inferiority for the prevention of VTE or VTE related death	—

Secondary

Measure	Time frame
Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion.	—
Safety	—

Countries

Austria, Belgium, Denmark, Finland, France, Germany, Hungary, Mexico, Netherlands, Norway, Poland, Portugal, South Africa, Spain, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026