Phase 3
Completed N=2,596
Dabigatran Etexilate vs Enoxaparin in Prevention of Venous Thromboembolism (VTE) Post Total Knee Replacement
Arthroplasty, Replacement, Knee · Thromboembolism
Source: ClinicalTrials.gov NCT00152971 ↗
Enrolled (actual)
2,596
Serious AEs
6.2%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period — 188; 219; 163 Participants — p=0.0234
Summary
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period |
188; 219; 163 | 0.0234 sig |
| SECONDARY Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period |
21; 20; 15 | 0.2139 |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period |
15; 20; 10 | 0.2309 |
| SECONDARY Number of Participants With Total Deep Vein Thrombosis During Treatment Period |
184; 218; 158 | 0.0194 sig |
| SECONDARY Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period |
7; 6; 5 | 0.5774 |
| SECONDARY Number of Participants With Pulmonary Embolism During Treatment Period |
6; 0; 5 | 0.7724 |
| SECONDARY Number of Participants Who Died During Treatment Period |
1; 1; 0 | 0.4968 |
| SECONDARY Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period |
7; 7; 10; 2; 1; 4 | — |
| SECONDARY Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period |
5; 5; 12; 23; 22; 21 | 0.1416 |
Eligibility Criteria
Inclusion criteria INCLUSION CRITERIA
- Patients scheduled to undergo a primary, unilateral elective total knee repla cement.
- Male or female 18 years of age or older.
- 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.
- Spinal or epidural anesthesia, for which more than 3 attempts (sticks) at placement were made, or the placement was traumatic.
Please note that patients, who are not excluded under this criterion, are to have the catheter pulled at the completion of surgery.
- Any history of hemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, arteriovenous (AV) malformation or aneurysm.
- History of VTE or pre-existing condition requiring anticoagulant therapy.
- Clinically relevant bleeding (e.g. gastrointestinal, pulmonary, intraocular or urogenital bleeding) within the last 6 months.
- Gastric or duodenal ulcer within the last 6 months.
- 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).
- Elevated AST or ALT >2x upper limit of normal, based on central lab results or local lab results within 1 month before enrollment.
- Known severe renal insufficiency (CrCl < 30 mL/min). In order to determine patient inclusion/exclusion, creatinine clearance (CrCl) needs to be calculated only if serum creatinine is elevated or renal insufficiency is suspected.
Data sourced from ClinicalTrials.gov (NCT00152971). 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. Informational only — not medical advice.