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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00320424 | Hip Fracture Study of GSK576428 (Fondaparinux Sodium) | PHASE3 | COMPLETED | 48 | — | — | Feb 16, 2006 | Oct 26, 2006 | Sep 4, 2018 | 1 | |
| NCT00139815 | Michelangelo - Oasis 5 | PHASE3 | COMPLETED | 20,078 | — | — | Apr 1, 2003 | Dec 1, 2005 | Sep 15, 2016 | - | — |
| NCT00038961 | A Study to Evaluate the Efficacy and Safety of Fondaparinux Sodium When Used With Intermittent Pneumatic Compression to Prevent Venous Thromboembolic (IPC) Versus IPC Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal Surgery (APOLLO). | PHASE3 | COMPLETED | 1,309 | — | — | Nov 1, 2001 | Oct 1, 2004 | Sep 1, 2016 | - | — |
Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE).
first occurrence of any component of death, myocardial infarction or
incidence of adjudicated major bleeding
the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE
| Arm | Type | Description |
|---|---|---|
| Enoxaparin | ACTIVE_COMPARATOR | - |
| Fondaparinux | EXPERIMENTAL | - |
| Placebo + intermittent pneumatic compression (IPC) | PLACEBO_COMPARATOR | - |
| fondaparinux + intermittent pneumatic compression (IPC) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Fondaparinux | DRUG | - |
| enoxaparin | DRUG | enoxaparin 1mg/kg s.c. injection twice daily x 2 to 8 days |
| fondaparinux sodium | DRUG | 2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES) |
| placebo | OTHER | placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES) |
Inclusion Criteria: * Patients undergoing hip fracture surgery within 10 days following the time of fracture of the hip (proximal femur) (or following the time of fracture estimated from trauma). Exclusion Criteria: * Active, clinically significant bleeding (excluding drainage).