Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00718224 | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Elective Knee Replacement Surgery | PHASE3 | COMPLETED | 1,150 | — | — | Jul 1, 2008 | May 1, 2009 | Jan 23, 2013 | 17 | United States, Argentina +15 |
| NCT00721760 | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery | PHASE3 | COMPLETED | 1,003 | — | — | Jul 1, 2008 | Oct 1, 2009 | Jan 23, 2013 | 25 | United States, Argentina +23 |
| NCT00694382 | Evaluation of AVE5026 in the Prevention of Venous Thromboembolism in Cancer Patients Undergoing Chemotherapy | PHASE3 | COMPLETED | 3,212 | — | — | Jun 1, 2008 | Nov 1, 2010 | Jan 23, 2013 | 411 | United States, Argentina +47 |
| NCT00697099 | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery | PHASE3 | COMPLETED | 2,326 | — | — | Jun 1, 2008 | Jun 1, 2009 | Jan 23, 2013 | 30 | United States, Argentina +28 |
| NCT00709904 | Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery | PHASE3 | COMPLETED | 469 | — | — | Jun 1, 2008 | Jan 1, 2010 | Jun 14, 2013 | 16 | United States, Belarus +14 |
| NCT00679588 | Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery | PHASE3 | COMPLETED | 4,413 | — | — | Apr 1, 2008 | Aug 1, 2010 | Dec 16, 2013 | 270 | United States, Argentina +37 |
| NCT00331838 | Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery | PHASE2 | COMPLETED | 705 | — | — | May 1, 2006 | Jun 1, 2007 | Jan 15, 2013 | 19 | Argentina, Bulgaria +17 |
VTE included any proximal or distal Deep Vein Thrombosis \[DVT\] (symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after central and blind review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
VTE included any Deep Vein Thrombosis \[DVT\] (proximal or distal, symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
VTE included any symptomatic Deep Vein Thrombosis \[DVT\] of lower or upper limbs and any non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of compression ultrasound or venography for DVT, ventilation/perfusion lung scan, pulmonary angiogram or spiral computer tomography lung scan for PE. VTE-related death included fatal PE and unexplained deaths without confirmatory autopsy. Any sudden death could be classified as fatal PE by the CIAC unless diagnostic test results strongly indicated an alternative diagnosis".
Participants alive and not having experienced VTE were right censored at last study drug injection plus 3 days. In order to correct for competing risks (Deaths other than VTE-related death), a model of cause-specific hazards was used to estimate the Cumulative incidence Function with Prentice non-parametric estimator.
VTE included any proximal or distal Deep Vein Thrombosis \[DVT\] (symptomatic or not) and non-fatal Pulmonary Embolism \[PE\] as confirmed by a Central Independent Adjudication Committee \[CIAC\] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE.
VTE include any Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE.
VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths includes fatal PE and deaths for other reason than PE.
VTE included any Deep Vein Thrombosis \[DVT\] identified on mandatory venography of the lower limbs; symptomatic DVT and/or non-fatal pulmonary embolism \[PE\] before mandatory examination; VTE related deaths included fatal PE or deaths which could not be attributed to a documented cause and for which PE could not be ruled out. All events were to be confirmed by a Central Independent Adjudication Committee \[CIAC\] based on venographies, scheduled or unscheduled, and other available diagnostic tests (ultrasonography, ventilation/perfusion lung scan, pulmonary angiography, autopsy report, etc).
| Arm | Type | Description |
|---|---|---|
| Semuloparin | EXPERIMENTAL | Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery To maintain the blind, placebo for Enoxaparin sodium: * 12 and 24 hours after surgery, then once daily if no SRI * 12 hours after surgery only if SRI |
| Enoxaparin | ACTIVE_COMPARATOR | Enoxaparin sodium 30 mg twice daily (20 mg once daily if Severe Renal Impairment \[SRI\]) for 7-10 days with an initial dose given 12 hours after surgery Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind |
| Placebo | PLACEBO_COMPARATOR | Placebo (for semuloparin) once daily until change in chemotherapy regimen |
| Semuloparin extension treatment | EXPERIMENTAL | Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days. |
| Placebo extension treatment | PLACEBO_COMPARATOR | Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days |
| Semuloparin 5 mg | EXPERIMENTAL | Semuloparin sodium 5 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Semuloparin 10 mg | EXPERIMENTAL | Semuloparin sodium 10 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Semuloparin 20 mg | EXPERIMENTAL | Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Semuloparin 40 mg | EXPERIMENTAL | Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Semuloparin 60 mg | EXPERIMENTAL | Semuloparin sodium 60 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Enoxaparin 40 mg | ACTIVE_COMPARATOR | Enoxaparin sodium 40 mg + Placebo (for Semuloparin sodium) once daily for 4-10 days with an initial dose given 12 hours before or 8 hours after surgery depending on the willingness of the investigator |
| Placebo pre-op / Semuloparin 20 mg | EXPERIMENTAL | Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 20 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery |
| Placebo pre-op / Semuloparin 40 mg | EXPERIMENTAL | Placebo (for Semuloparin sodium) + Placebo (for Enoxaparin sodium) 12 hours before surgery then, Semuloparin sodium 40 mg + Placebo (for Enoxaparin sodium) once daily for 4-10 days with an initial dose given 8 hours after surgery |
| Name | Type | Description |
|---|---|---|
| Semuloparin sodium | DRUG | 0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection |
| Enoxaparin | DRUG | 0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 mL pre-filled syringe Subcutaneous injection |
| Placebo | DRUG | 0.3 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection |
| Enoxaparin sodium | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection |
| Placebo (for semuloparin) | DRUG | 0.4 mL solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component Subcutaneous injection |
| Open-label Semuloparin sodium | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily with an initial dose given 8 hours after surgery |
| Placebo (for Semuloparin sodium) | DRUG | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection once daily |
| Placebo (for Enoxaparin sodium) | DRUG | 0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection |
Inclusion Criteria: \- Knee replacement surgery or revision of at least one component of a knee prosthesis implanted ≥ 6 months prior to study entry. Exclusion Criteria: * Any major orthopedic surgeries in the 3 months prior to study; * Deep vein thrombosis or pulmonary embolism within the last 1...