Prophylactic treatment for the prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery.
Conditions
Interventions
Trade Name: Exanta
Pharmaceutical Form: Tablet
INN or Proposed INN: ximelagatran
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 24-
Pharmaceutical form of the pla
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed consent 2. Female or male aged 18 years and over 3. Patient scheduled for primary elective hip replacement or patient requiring surgery for hip fracture, such as osteosynthesis or acute hip replacement due to one-sided fracture of the collum femoralis, pertrochanteric and subtrochanteric fracture. The patient is judged to be a candidate for 4-5 weeks of extended prophylaxis. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Contraindications for melagatran/ximelagatran and/or enoxaparin 2. Calculated creatinine clearance 2 times the ULN and/or known liver disease 6. (MI), Ischemic stroke or TIA, systemic embolism or VTE within 30 days of enrolment 7. Post-thrombotic syndrome 8. Active malignancy and/or cytostatic treatment within the past 6 months. 9. Increased risk of bleeding including: ? History of intracranial, intraocular, retro peritoneal, gastrointestinal bleeding, active (unhealed) gastric or duodenal ulcer or spinal bleeding, recent major trauma, brain, spinal or ophthalmic surgery, except for trauma associated with hip fracture (if applicable) within 30 days not due to a known reversible cause (at the discretion of the Investigator) ? Severe uncontrolled hypertension (persistent systolic blood pressure =180 or diastolic blood pressure =110 mm Hg, with or without anti-hypertensive therapy) ? Concomitant treatment with other anticoagulants ? Concomitant treatment with antiplatelet medications (N.B. For ASA >162mg/daily, for occasional use ASA up to 500mg is allowed) ? Long-acting NSAID with a t ½ >20hours ? Treatment with fibrinolytic agents within 2 days prior to start of investigational product. 10. Anaemia (Hb <100g/L) 11. Platelet count <100x109/L 12. Known medication addiction or alcohol abuse 13. Childbearing potential, pregnancy, lactation (females of childbearing potential, <55 years of age, may be included, provided that an adequate method of birth control, as judged by the Investigator, is used and a negative pregnancy test is obtained before randomization) 14. Mental condition making the patient unable to understand the aims, investigational procedures or possible consequences of the study 15. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the study centre) 16. Previous enrolment or randomization to treatment in the present study 17. Participation in a clinical study during the last 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: See Clinical Study Protocol page 2/70.;Secondary Objective: See Clinical Study Protocol page 3/70.;Primary end point(s): See Clnical study protocol page 5/70. | — |
Countries
Finland, Germany, Hungary, Portugal, Spain, Sweden
Outcome results
None listed