Melagatran/Ximelagatran Versus Enoxaparin for the Prevention of Venous Thromboembolic Events
Phase 3
Terminated
- Conditions
- Thromboembolism
- Registration Number
- NCT00206089
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3300
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Non-inferiority for the prevention of VTE or VTE related death
- Secondary Outcome Measures
Name Time Method Superiority regarding major bleeding or the percentage of patients requiring donor blood transfusion. Safety
Trial Locations
- Locations (1)
Research Site
🇨ðŸ‡Zurich, Switzerland