Phase 2
N=512
A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.
Arthroplasty, Replacement, Knee · Venous Thrombosis
Bottom Line
View on ClinicalTrials.gov: NCT00246025 ↗Enrolled (actual)
512
Serious AEs
2.0%
Results posted
Dec 2010
Primary outcome: Primary: Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period. — 56.4; 39.6; 32.7; 24 percentage of participants — p=0.0155
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dabigatran etexilate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Have a Composite Endpoint Consisting of Total Venous Thromboembolic Event (VTE) and All Cause Mortality During the Treatment Period. |
56.4; 39.6; 32.7; 24 | 0.0155 sig |
| SECONDARY Percentage of Participants Who Have a Composite of Major VTE (Defined as Proximal DVT and PE) and VTE Related Mortality |
5.8; 1.7; 1.8; 0 | 0.1124 |
| SECONDARY Percentage of Participants Who Have Proximal DVT (Deep Vein Thrombosis) During Treatment Period |
5.8; 1.7; 1.8; 0 | 0.1124 |
| SECONDARY Percentage of Participants With Symptomatic DVT (Deep Vein Thrombosis) |
1.6; 0.8; 1.6; 0.8 | 0.6107 |
| SECONDARY Percentage of Participants Who Have Total DVT (Deep Vein Thrombosis) During Treatment Period |
56.4; 39.6; 32.7; 24.0 | 0.0155 sig |
| SECONDARY Number of Participants With Pulmonary Embolism During Treatment Period |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants Who Died During Treatment Period |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Bleeding Events During Treatment Period |
1; 1; 0; 3; 4; 1 | 1.0000 |
| SECONDARY Blood Transfusion |
75; 82; 77; 76; 5; 4 | — |
| SECONDARY Volume of Blood Loss |
82.8; 90.5; 67.5; 77.3 | — |
| SECONDARY Laboratory Analyses |
2; 1; 0; 0; 0; 0 | — |
Summary
The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.
Eligibility Criteria
Inclusion criteria Inclusion criteria
- Patients scheduled to undergo a primary, unilateral elective total knee replacement
- Male or Female 20 years of age or order
- Patients weighing at least 40 kg
- Written informed consent prior to the start of study participation
Exclusion criteria Exclusion criteria
- History of bleeding diathesis
- Constitutional or acquired coagulation disorders that in the investigator's judgment puts the patient at excessive risk for bleeding
- Major surgery or trauma (e.g. hip fracture) within the last 3 months
- Recent unstable cardiovascular disease, such as uncontrolled hypertension at the time of enrollment (investigator's judgment) or history of myocardial infarction within the last 3 months
- Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV (arteriovenous) malformation or aneurysm or recent bleeding history
- Condition requiring anti-coagulant therapy
- Elevated AST(Aspartate Aminotransferase) , ALT(Alanine Aminotransferase), or any history of clinically relevant liver disease
- Patients with a history of clinically significant renal diseases or with elevated creatinine values
Data sourced from ClinicalTrials.gov (NCT00246025). 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.