The EXTEND study: A randomized, double-blind, parallel-group, phase IIIb, 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. - EXTEND

Phase 1

Conditions: Prophylactic treatment for the prevention of venous thromboembolic events in patients undergoing elective hip replacement or hip fracture surgery.

Registration Number: EUCTR2004-002746-35-ES

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3300

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

1. Contraindications for melagatran/ximelagatran and/or enoxaparin

2. Calculated creatinine clearance <30mL/min
Creatinine clearance (mL/min)= [b x (140 – age (years)) x weight (kg)]/serum creatinine (mikromol/L)
b= 1.23 (male); 1.04 (female)

3. History of heparin-induced thrombocytopenia

4. Delay of more than 72 hours between trauma and planned surgery, applicable for hip fracture patients

5. ALAT >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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: See Clinical Study Protocol<br><br>;Secondary Objective: See Clinical Study Protocol;Primary end point(s): The primary variable in the study is the composite endpoint of proximal DVT at the end of the study treatment period, any clinically suspected and objectively verified symptomatic proximal or distal DVT, clinically suspected and objectively verified PE and/or VTE-related death or deaths for which a VTE-related cause cannot be excluded. <br>The assessment of the efficacy of melagatran/ximelagatran relative to the comparator will be done using the Intention To Treat (ITT) population. A sensitivity analysis using the Per Protocol (PP) population will be carried out<br>

Secondary Outcome Measures

Name	Time	Method

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