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 half dose (i.e. 75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 28-35 days, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery. - RE-NOVATE (Extended thromboembolism prevention after hip surgery)

Conditions: Prevention of venous thromboembolism following primary elective total hip replacement surgery

Registration Number: EUCTR2004-001988-21-DE

Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3330

Inclusion Criteria

1. Patients scheduled to undergo a primary, unilateral elective total hip 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. (deleted)
6. Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm
7. History of VTE or pre-existing condition requiring anticoagulant therapy
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 6 months
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 hip replacement surgery or anticipated need during the study treatment period (COX-2 selective inihibitors are allowed)
15. Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb
16. Pre-menopausal women (last menstruation ?1 year prior to signing informed consent) who: are pregnant, nursing or are of child-bearing potential and are NOT practising acceptable methods of birth control, or do NOT plan to continue practising an acceptable method throughout the study
17. Known allergy to radio opaque contrast media or iodine
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-MODEL or RE-MOBILIZE

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the comparative efficacy of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.;Secondary Objective: To determine the comparative safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.;Primary end point(s): Composite of total venous thromboembolic events (VTE) and all-cause mortality during the treatment period.<br>Total VTE includes deep vein thrombosis [DVT] (proximal and distal) as detected by routine venography; symptomatic DVT, confirmed by venous duplex ultrasound, venography or by autopsy; and pulmonary embolism confirmed by pulmonary ventilation-perfusion (V-Q) scintigraphy and chest X-ray or pulmonary angiography or spiral CT.<br>

Secondary Outcome Measures