A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery. - RE-MODEL (Thromboembolism prevention after knee surgery)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2010

Inclusion Criteria

1. Patients scheduled to undergo a primary, unilateral elective total knee replacement
2. Male or female being 18 years or older
3. Patients weighing at least 40 kg
4. Written informed consent for study participation.

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. History of bleeding diathesis
2. Constitutional or acquired coagulation disorders that in the investigator’s judgement puts the patient at excessive risk for bleeding
3. Major surgery or trauma (e.g. hip fracture) within the last 3 months
4. Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrolment (investigator’s judgement) or history of myocardial infarction within the last 3 months
5. Spinal or epidural anaesthesia, for which more than 3 attempts at placement were made (sticks), or the placement was traumatic.
6. Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm
7. History of VTE still requiring specific treatment
8. Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months
9. Gastric or duodenal ulcer within the last year
10. Liver disease expected to have any potential impact on survival (e.g. hepatitis B or C, cirrhosis, but not Gilbert’s syndrome or hepatitis A with complete recovery)
11. Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrolment
12. Known severe renal insufficiency (CrCl < 30 ml/min).
13. Elevated creatinine, which in the investigator’s opinion contraindicates venography
14. Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin > 160 mg/day or NSAID with t½ > 12 hours within 7 days prior to knee replacement surgery or anticipated need during the study treatment period (COX-2 selective inhibitors are allowed)
15. Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb
16. Pre-menopausal women (last menstruation 17. Known allergy to radio opaque contrast media
18. History of thrombocytopenia (incl. heparin induced thrombocytopenia) or a platelet count < 100,000 cells/microliter at visit 1
19. Allergy to heparins or dabigatran
20. Active malignant disease or current cytostatic treatment
21. Participation in a clinical trial during the last 30 days
22. Leg amputee
23. Known alcohol or drug abuse which would interfere with completion of the study
24. Contraindications to enoxaparin
25. Previous participation in this study or RE-NOVATE or RE-MOBILIZE

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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