Phase 3
N=3,463
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Thromboembolism · Arthroplasty, Replacement, Hip
Bottom Line
View on ClinicalTrials.gov: NCT00168818 ↗Enrolled (actual)
3,463
Serious AEs
7.6%
Results posted
Dec 2010
Primary outcome: Primary: Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period — 53; 75; 60 Participants — p=0.5648
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dabigatran etexilate (Drug); enoxaparin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jul 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period |
53; 75; 60 | 0.5648 |
| SECONDARY Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period |
28; 38; 36 | 0.3256 |
| SECONDARY Proximal Deep Vein Thrombosis During Treatment Period |
23; 35; 33 | 0.1863 |
| SECONDARY Total Deep Vein Thrombosis During Treatment Period |
46; 72; 57 | 0.3173 |
| SECONDARY Symptomatic Deep Vein Thrombosis During Treatment Period |
6; 9; 1 | 0.0694 |
| SECONDARY Pulmonary Embolism During Treatment Period |
5; 1; 3 | 0.5062 |
| SECONDARY Death During Treatment Period |
3; 3; 0 | 0.1240 |
| SECONDARY Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period |
1; 4; 5; 0; 1; 3 | — |
| SECONDARY Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period |
23; 15; 18; 48; 55; 40 | 0.4352 |
| SECONDARY Blood Transfusion |
517; 531; 542; 259; 266; 286 | — |
| SECONDARY Volume of Blood Loss |
457; 435; 463 | — |
| SECONDARY Laboratory Analyses |
11; 16; 29; 0; 0; 0 | — |
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 of venous thromboembolism in patients with primary elective total hip replacement surgery.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00168818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.