Phase 3
Completed N=2,076
RE-MODEL Dabigatran Etexilate 150mg or 220mg Once Daily (o.d.) Versus (v.s.) Enoxaparin 40mg o.d. for Prevention of Thrombosis After Knee Surgery
Arthroplasty, Replacement, Knee · Thromboembolism
Source: ClinicalTrials.gov NCT00168805 ↗
Enrolled (actual)
2,076
Serious AEs
5.7%
Results posted
Dec 2010
Primary outcomePrimary: Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period — 183; 213; 193 Participants — p=0.6648
Summary
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period |
183; 213; 193 | 0.6648 |
| SECONDARY Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period |
13; 20; 18 | 0.3760 |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period |
13; 18; 17 | 0.4715 |
| SECONDARY Number of Participants With Total Deep Vein Thrombosis During Treatment Period |
182; 211; 192 | 0.6463 |
| SECONDARY Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period |
1; 3; 8 | 0.0385 sig |
| SECONDARY Number of Participants With Pulmonary Embolism During Treatment Period |
0; 1; 1 | 1.0000 |
| SECONDARY Number of Participants Who Died During Treatment Period |
1; 1; 1 | 1.0000 |
| SECONDARY Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period |
4; 3; 2; 0; 1; 0 | — |
| SECONDARY Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period |
10; 9; 9; 40; 48; 37 | 0.8209 |
| SECONDARY Blood Transfusion |
242; 253; 265; 87; 86; 120 | — |
| SECONDARY Volume of Blood Loss |
187; 190; 191 | — |
| SECONDARY Laboratory Analyses |
9; 6; 9; 0; 0; 0 | — |
Eligibility Criteria
Inclusion criteria
Inclusion criteria (selected):
- Patients (18 years or older) scheduled to undergo a primary, unilateral, elect ive total knee 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, arteriovenous (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 aspartate aminotransferase (AST) or alanine transaminase (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 pote ntial and are not practising or do not plan to continue practising acceptable me thods of birth control
- Allergy to radio opaque contrast media or iodine, heparins (incl. heparin indu ced thrombocytopenia) or dabigatran
- Contraindications to enoxaparin
- Participation in a clinical trial during the last 30 days
Data sourced from ClinicalTrials.gov (NCT00168805). 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.