Phase 3
Completed N=3,148
Regulation of Coagulation in Orthopedic Surgery to Prevent Deep Vein Thromboembolism (DVT) and Pulmonary Embolism (PE). A Study of BAY59-7939 in the Prevention of Venous Thrombo Embolism (VTE) in Subjects Undergoing Elective Total Knee Replacement.
Source: ClinicalTrials.gov NCT00362232 ↗Enrolled (actual)
3,148
Serious AEs
7.8%
Results posted
Jun 2012
Primary outcomePrimary: Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population — 6.71; 9.34 Percentage of participants — p=<0.001
Summary
The purpose of this study is to assess if 10 mg BAY59-7939, taken once daily as a tablet, is safe and prevents blood clot which may form after a knee replacement operation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population |
6.71; 9.34 | <0.001 sig |
| PRIMARY Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population. |
6.94; 10.11 | 0.012 sig |
| SECONDARY Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE |
1.09; 1.47 | 0.456 |
| SECONDARY Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE. |
1.16; 1.98 | 0.124 |
| SECONDARY Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population. |
1.04; 1.48 | — |
| SECONDARY Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population. |
1.14; 1.88 | — |
| SECONDARY Incidence of DVT (Proximal, Distal) Per Protocol Population. |
6.37; 8.66 | — |
| SECONDARY Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population. |
6.32; 8.97 | — |
| SECONDARY Incidence of Symptomatic VTE During Follow-up Per Protocol Population. |
0.35; 0.11 | — |
| SECONDARY Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population. |
0.31; 0.21 | — |
| SECONDARY The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit |
2.04; 2.33 | — |
| SECONDARY Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population. |
6.71; 9.11 | 0.054 |
| SECONDARY Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population. |
6.84; 9.80 | 0.017 sig |
| SECONDARY Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population. |
1.09; 1.67 | 0.270 |
| SECONDARY Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population. |
1.25; 2.25 | 0.074 |
| SECONDARY Treatment-emergent Major Bleedings Per Safety Population. |
0.66; 0.27 | 0.110 |
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 18 years or above
- Patients scheduled for elective total knee replacement
Exclusion Criteria
- Active bleeding or high risk of bleeding contraindicating treatment with Low Molecular Weight Heparin (LMWH)
- Contraindication listed in the labeling or conditions precluding subject treatment with enoxaparin or requiring dose adjustment (e.g. severe renal impairment, please refer to the local label of enoxaparin in your country)
- Conditions prohibiting bilateral venography (e.g. amputation of 1 leg, allergy to contrast media)
Data sourced from ClinicalTrials.gov (NCT00362232). 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.