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

AstraZeneca

Status and phase

Terminated

Phase 3

Conditions

Thromboembolism

Treatments

Drug: EXANTA

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206089

D4003C00030

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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.