Status:
COMPLETED
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Thromboembolism
Arthroplasty, Replacement, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention o...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Inclusion criteria (selected):
- Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
- Written Informed Consent
- Exclusion criteria
- Exclusion criteria (selected):
- Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
- Active malignant disease or current cytostatic treatment
- Known severe renal insufficiency
- Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal
- Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
- Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control
- Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
- Contraindications to enoxaparin
- Participation in a clinical trial during the last 30 days
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
3494 Patients enrolled
Trial Details
Trial ID
NCT00168818
Start Date
November 1 2004
Last Update
May 19 2014
Active Locations (116)
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1
1160.48.06108 Canberra Hospital
Garren, Australian Capital Territory, Australia
2
1160.48.06106 St George Public Hospital
Kogarah, New South Wales, Australia
3
1160.48.06110 Suite 13 level 4
Lismore, New South Wales, Australia
4
1160.48.06105 Flinders Medical Centre
Bedford Park, South Australia, Australia