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

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Melagatran; Ximelagatran

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.